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The Effects of an Antioxidant Formulation on Ocular Blood Flow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01930487
Recruitment Status : Completed
First Posted : August 29, 2013
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
ScienceBased Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Primary Open Angle Glaucoma
Interventions Dietary Supplement: dietary supplement with antioxidants
Dietary Supplement: Placebo
Enrollment 47
Recruitment Details 47 patients were recruited for the study
Pre-assignment Details 1 subject started but did not complete the baseline examination and was not randomized to either treatment arm.
Arm/Group Title Supplement With Antioxidants, Then Placebo Placebo, Then Supplement With Antioxidants
Hide Arm/Group Description dietary supplement with antioxidants in the first intervention period, followed by placebo supplement in the second intervention period placebo supplement in the second intervention period, followed by dietary supplement with antioxidants in the second intervention period
Period Title: First Intervention (30 Days)
Started 21 25
Completed 19 23
Not Completed 2 2
Period Title: Washout Period (3 Weeks)
Started 19 23
Completed 19 23
Not Completed 0 0
Period Title: Second Intervention (30 Days)
Started 19 23
Completed 19 23
Not Completed 0 0
Arm/Group Title Participants Completing Study
Hide Arm/Group Description Participants who completed both arms of the crossover study
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
patients who completed both periods of the crossover study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
67  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
24
  57.1%
Male
18
  42.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  16.7%
White
34
  81.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
Diabetes (Type 2)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
yes 21
no 21
Hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
yes 16
no 26
Study Eye  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
right 24
left 18
Duration of OAG  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
15  (8)
1.Primary Outcome
Title Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)
Hide Description change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: % zero pixels
-0.026  (0.008) 0.011  (0.007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.037
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.011
Estimation Comments dietary supplement with antioxidants - placebo
2.Primary Outcome
Title Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)
Hide Description change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: % zero pixels
-0.016  (0.007) 0.009  (0.007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0249
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.025
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.011
Estimation Comments dietary supplement with antioxidants - placebo
3.Secondary Outcome
Title Change in Ocular Perfusion Pressure
Hide Description change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: mm Hg
1.5  (0.9) 1.4  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9147
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.3
Estimation Comments dietary supplement with antioxidants - placebo
4.Secondary Outcome
Title Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)
Hide Description change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: cm/s
0.74  (0.41) -0.94  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0070
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.59
Estimation Comments dietary supplement with antioxidants - placebo
5.Secondary Outcome
Title Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)
Hide Description change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: cm/s
0.54  (0.15) -0.43  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method paired t-test, 2-sidede
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.97
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments dietary supplement with antioxidants - placebo
6.Secondary Outcome
Title Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)
Hide Description change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: cm/s
0.30  (0.14) -0.16  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0476
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.23
Estimation Comments dietary supplement with antioxidants – placebo
7.Secondary Outcome
Title Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)
Hide Description change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: cm/s
0.31  (0.16) -0.14  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0352
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments dietary supplement with antioxidants – placebo
8.Secondary Outcome
Title Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)
Hide Description change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: cm/s
0.35  (0.13) -0.17  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0208
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.21
Estimation Comments dietary supplement with antioxidants – placebo
9.Secondary Outcome
Title Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)
Hide Description change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: cm/s
0.27  (0.05) -0.11  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments dietary supplement with antioxidants – placebo
10.Secondary Outcome
Title Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)
Hide Description change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: cm/s
0.17  (0.05) -0.07  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments dietary supplement with antioxidants – placebo
11.Secondary Outcome
Title Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)
Hide Description change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: cm/s
0.15  (0.05) -0.06  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0081
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments dietary supplement with antioxidants – placebo
12.Secondary Outcome
Title Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)
Hide Description change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: ratio
-0.007  (0.004) -0.005  (0.006)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8191
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.002
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.008
Estimation Comments dietary supplement with antioxidants – placebo
13.Secondary Outcome
Title Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)
Hide Description change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: ratio
-0.018  (0.006) 0.000  (0.006)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0482
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.018
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.009
Estimation Comments dietary supplement with antioxidants – placebo
14.Secondary Outcome
Title Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)
Hide Description change (post-treatment - pre-treatment) in nasal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: ratio
-0.013  (0.006) 0.005  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0230
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.019
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.0230
Estimation Comments dietary supplement with antioxidants – placebo
15.Secondary Outcome
Title Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)
Hide Description change (post-treatment - pre-treatment) in temporal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 42 42
Mean (Standard Error)
Unit of Measure: ratio
-0.009  (0.006) 0.004  (0.005)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1202
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.013
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.008
Estimation Comments dietary supplement with antioxidants – placebo
16.Secondary Outcome
Title Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
Hide Description change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
1.71  (0.56) -0.84  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.83
Estimation Comments dietary supplement with antioxidants – placebo
17.Secondary Outcome
Title Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
Hide Description change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
-0.24  (0.53) -1.03  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3347
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.80
Estimation Comments dietary supplement with antioxidants – placebo
18.Secondary Outcome
Title Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
Hide Description change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.58  (0.20) -0.44  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0094
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.35
Estimation Comments dietary supplement with antioxidants – placebo
19.Secondary Outcome
Title Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
Hide Description change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.51  (0.23) -0.41  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.92
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments dietary supplement with antioxidants – placebo
20.Secondary Outcome
Title Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
Hide Description change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.56  (0.22) -0.46  (0.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0067
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments dietary supplement with antioxidants – placebo
21.Secondary Outcome
Title Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
Hide Description change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.03  (0.16) 0.13  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6938
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.25
Estimation Comments dietary supplement with antioxidants – placebo
22.Secondary Outcome
Title Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM
Hide Description change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.24  (0.19) -0.32  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0805
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.56
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments dietary supplement with antioxidants – placebo
23.Secondary Outcome
Title Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM
Hide Description change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.38  (0.27) 0.03  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2451
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.29
Estimation Comments dietary supplement with antioxidants – placebo
24.Secondary Outcome
Title Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM
Hide Description change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.60  (0.19) -0.18  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0323
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.34
Estimation Comments dietary supplement with antioxidants – placebo
25.Secondary Outcome
Title Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
Hide Description change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.09  (0.18) -0.16  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3440
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.26
Estimation Comments dietary supplement with antioxidants – placebo
26.Secondary Outcome
Title Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM
Hide Description change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.29  (0.06) -0.08  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0119
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.13
Estimation Comments dietary supplement with antioxidants – placebo
27.Secondary Outcome
Title Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
Hide Description change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.26  (0.07) -0.14  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments dietary supplement with antioxidants – placebo
28.Secondary Outcome
Title Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM
Hide Description change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.16  (0.07) -0.16  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0137
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments dietary supplement with antioxidants – placebo
29.Secondary Outcome
Title Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
Hide Description change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.18  (0.07) 0.01  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0866
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments dietary supplement with antioxidants – placebo
30.Secondary Outcome
Title Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM
Hide Description change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.10  (0.07) -0.13  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0656
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments dietary supplement with antioxidants – placebo
31.Secondary Outcome
Title Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM
Hide Description change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: cm/s
0.20  (0.08) 0.01  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0626
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments dietary supplement with antioxidants – placebo
32.Secondary Outcome
Title Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM
Hide Description change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: ratio
-0.008  (0.007) -0.005  (0.009)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8100
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.003
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.013
Estimation Comments dietary supplement with antioxidants – placebo
33.Secondary Outcome
Title Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM
Hide Description change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: ratio
-0.005  (0.006) -0.004  (0.009)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9556
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.001
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.010
Estimation Comments dietary supplement with antioxidants – placebo
34.Secondary Outcome
Title Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM
Hide Description change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: ratio
-0.019  (0.010) -0.004  (0.011)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3414
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.015
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.015
Estimation Comments dietary supplement with antioxidants – placebo
35.Secondary Outcome
Title Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM
Hide Description change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: ratio
-0.017  (0.007) 0.004  (0.007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0330
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.021
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.009
Estimation Comments dietary supplement with antioxidants – placebo
36.Secondary Outcome
Title Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM
Hide Description change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: ratio
-0.005  (0.007) 0.005  (0.007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3326
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.010
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.010
Estimation Comments dietary supplement with antioxidants – placebo
37.Secondary Outcome
Title Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM
Hide Description change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: ratio
-0.022  (0.010) 0.005  (0.007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0348
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.027
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.012
Estimation Comments dietary supplement with antioxidants – placebo
38.Secondary Outcome
Title Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM
Hide Description change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: ratio
-0.006  (0.009) 0.010  (0.007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2089
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.016
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.012
Estimation Comments dietary supplement with antioxidants – placebo
39.Secondary Outcome
Title Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM
Hide Description change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: ratio
-0.012  (0.009) -0.001  (0.007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3738
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.010
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.012
Estimation Comments dietary supplement with antioxidants – placebo
40.Secondary Outcome
Title Change in Ocular Perfusion Pressure - DM
Hide Description change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: mm Hg
0.2  (1.2) -1.1  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4470
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.7
Estimation Comments dietary supplement with antioxidants – placebo
41.Secondary Outcome
Title Change in Ocular Perfusion Pressure - No DM
Hide Description change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: mm Hg
2.8  (1.4) 3.8  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6382
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.1
Estimation Comments dietary supplement with antioxidants – placebo
42.Secondary Outcome
Title Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM
Hide Description change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: % zero pixels
-0.031  (0.009) 0.012  (0.010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments [Not Specified]
Method paird t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.043
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.012
Estimation Comments dietary supplement with antioxidants – placebo
43.Secondary Outcome
Title Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM
Hide Description change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: % zero pixels
-0.021  (0.014) 0.010  (0.009)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1045
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.030
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.018
Estimation Comments dietary supplement with antioxidants – placebo
44.Secondary Outcome
Title Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM
Hide Description change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: % zero pixels
-0.005  (0.009) 0.000  (0.008)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6941
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.005
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.013
Estimation Comments dietary supplement with antioxidants – placebo
45.Secondary Outcome
Title Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM
Hide Description change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes
Time Frame baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
patients completing both study periods
Arm/Group Title Dietary Supplement With Antioxidants Placebo
Hide Arm/Group Description:

Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Placebo identical in appearance to active

Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants

Overall Number of Participants Analyzed 21 21
Mean (Standard Error)
Unit of Measure: % zero pixels
-0.028  (0.009) 0.018  (0.010)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dietary Supplement With Antioxidants, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0138
Comments [Not Specified]
Method paired t-test, 2-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.046
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.017
Estimation Comments dietary supplement with antioxidants – placebo
Time Frame Four weeks for each intervention, with a 3-week wash out period between interventions
Adverse Event Reporting Description Safety population included all participants who completed study. (45 patients with OAG were enrolled, 42 of which were followed through to completion of the study. Three patients discontinued study participation due to difficulty in adhering to study visit timeline.)
 
Arm/Group Title Supplement w/ Antioxidants Placebo
Hide Arm/Group Description

dietary supplement with antioxidants

dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

placebo supplement

Placebo: Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants

All-Cause Mortality
Supplement w/ Antioxidants Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Supplement w/ Antioxidants Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Supplement w/ Antioxidants Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Brent Siesky, PhD, Assistant Director
Organization: Ocular Vascular Research Center, Indiana University School of Medicine
Phone: 317-278-0177
Responsible Party: ScienceBased Health
ClinicalTrials.gov Identifier: NCT01930487     History of Changes
Other Study ID Numbers: 007
First Submitted: August 9, 2013
First Posted: August 29, 2013
Results First Submitted: May 31, 2016
Results First Posted: December 5, 2016
Last Update Posted: December 5, 2016