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Dietary Nitrate Supplements and Ischemic Stroke Recovery

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ClinicalTrials.gov Identifier: NCT02838901
Recruitment Status : Completed
First Posted : July 20, 2016
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stroke
Ischemic Stroke
Cerebrovascular Accident
Interventions Drug: Beet it Beetroot juice
Drug: Beet It Placebo Beetroot juice
Enrollment 18
Recruitment Details The study enrolled adults who have suffered an ischemic stroke with minimum impairments defined by NIHSS scores and physical function measurements.
Pre-assignment Details From June 2012 to June 2016, patients who are admitted to the Stroke Unit and who are within 96 hours of symptom onset, were screened for eligibility by reviewing their admitting history and physicals and imaging results.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle.

Nine participants were randomized to the Beet It Beetroot Juice arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.

Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.

Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral blood flow.

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Nine participants were randomized to the Beet It Beetroot Juice Placebo arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.

Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.

Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral b

Period Title: Overall Study
Started 9 9
Completed 7 7
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             1             1
Lost to Follow-up             1             1
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo Total
Hide Arm/Group Description

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Total of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
Baseline characteristics were balanced with regard to admission NIHSS, age, sex, race, risk factors, baseline gait speed, and baseline nitrate/nitrite levels.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  44.4%
4
  44.4%
8
  44.4%
>=65 years
5
  55.6%
5
  55.6%
10
  55.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Age (yrs)
Number Analyzed 9 participants 9 participants 18 participants
63.5  (8.6) 66.3  (9.2) 64.9  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
4
  44.4%
2
  22.2%
6
  33.3%
Male
5
  55.6%
7
  77.8%
12
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  33.3%
1
  11.1%
4
  22.2%
White
5
  55.6%
7
  77.8%
12
  66.7%
More than one race NA [1]  NA [1]  NA [2] 
Unknown or Not Reported
1
  11.1%
1
  11.1%
2
  11.1%
[1]
more than one race reported as other/unknown
[2]
Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 18 participants
9
 100.0%
9
 100.0%
18
 100.0%
nitrate and nitrite levels  
Mean (Standard Deviation)
Unit of measure:  micromoles/L
Baseline Nitrate Number Analyzed 9 participants 9 participants 18 participants
63.9  (77.2) 27.0  (16.0) 45.5  (57.3)
Baseline Nitrite Number Analyzed 9 participants 9 participants 18 participants
0.17  (0.14) 0.13  (0.08) 0.15  (0.11)
gait speed   [1] 
Mean (Full Range)
Unit of measure:  M/s
Number Analyzed 8 participants 9 participants 17 participants
0.23
(0.07 to 0.36)
0.22
(0.08 to 0.23)
0.22
(0.08 to 0.32)
[1]
Measure Analysis Population Description: A total of 17 participants had baseline gait speed data available
1.Primary Outcome
Title Adherence With Intervention
Hide Description The primary outcome for this trial is feasibility, which will be measured by how well the participants followed instructions on taking Beet It organic beetroot juice or placebo once a day for 30 days.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants were lost to follow-up by 30 days, therefore the analysis included 8 participants in each group.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Overall Number of Participants Analyzed 8 8
Mean (Inter-Quartile Range)
Unit of Measure: percentage of participants
93.5
(80 to 100)
100
(100 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments The null hypothesis was used, and the assumption was there would be no difference in adherence between the Active Juice and the Placebo Juice, and therefore a two-sided t approximation was reported. Since this was a pilot study, power calculations were not performed. The adherence in the two groups was compared using the Wilcoxon two-sample test.
Type of Statistical Test Other
Comments This was a descriptive analysis, and was based on the overall assessment of feasibility of the intervention.
Statistical Test of Hypothesis P-Value 0.058
Comments The p value is not adjusted for multiple comparisons
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Adverse Treatment-altering Events
Hide Description Adverse events that lead to treatment discontinuation
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle.

Nine participants were randomized to the Beet It Beetroot Juice arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.

Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.

Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral blood flow.

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Nine participants were randomized to the Beet It Beetroot Juice Placebo arm. Participants had blood drawn on study day 1 and day 30 for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) plus vitamin C 500 mg daily. On day 30, gait speed (using the 4 m walk) was assessed.

Eighteen participants were consented, 15 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days.

Participants selected for the MRI portion of the study had a brain MRI performed on study day 30 to measure cerebral b

Overall Number of Participants Analyzed 9 9
Measure Type: Number
Unit of Measure: participants
1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments Null hypothesis was assumed, no power calculation was done since this was a pilot study.
Type of Statistical Test Other
Comments This was a descriptive analysis and was under the goal of assessing safety of the intervention.
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Primary Outcome
Title Change in Plasma Nitrate Levels, Micromoles/Liter
Hide Description This is the proof-of-concept to see if plasma levels change in those randomized to the active beet juice compared to placebo. Comparing baseline values against values at 30 days.
Time Frame after 30 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The median treatment-specific changes in nitrate were analyzed using comparison of pre to post-dosing plasma on day 1. Beetroot It Beetroot juice (Active) was associated with an increase in plasma nitrate and a trend towards increased nitrite levels. The analysis included 8 participants per group since 2 did not come back for follow-up at 30 days.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Overall Number of Participants Analyzed 8 7
Median (Inter-Quartile Range)
Unit of Measure: micromoles/L
174.76
(149.68 to 241.09)
0.678
(-1.678 to 2.060)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments The null hypothesis was assumed, and no power calculation was performed since this was a pilot study.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Primary Outcome
Title Change in Plasma Nitrite Levels, Micromoles/Liter
Hide Description This is the proof-of-concept to see if plasma levels change in those randomized to the active beet juice compared to placebo. Comparing baseline values against values at 30 days.
Time Frame after 30 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The median treatment-specific changes in nitrate were analyzed using comparison of pre to post-dosing plasma on day 1. Beetroot It Beetroot juice (Active) was associated with an increase in plasma nitrate and a trend towards increased nitrite levels. The analysis included 8 participants in active and 7 in placebo based on follow-up at 30 d.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Overall Number of Participants Analyzed 8 7
Median (Inter-Quartile Range)
Unit of Measure: micromoles/L
0.114
(0.044 to 0.158)
0.014
(0.002 to 0.028)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments This was a descriptive analysis for a pilot study, and no power calculations were performed.
Statistical Test of Hypothesis P-Value 0.1023
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Gait Speed Change From Baseline
Hide Description Gait speed is measured by the time it takes to walk 10 meters. Baseline was reported.Change in gait speed from baseline was assessed at 30 and 90 days. Non-ambulatory at baseline is defined as gait speed less than 0.1 m/s.
Time Frame baseline, 30, and 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
There were 8 participants in the Active and 8 in the placebo because they did not follow-up at 30 days. BL ambulatory refers to only those participants were able to walk at baseline immediately after enrollment. For this analysis, there were only 6 participants in the active and 7 in the placebo at 30 days and 4 and 5 at 90 days, respectively.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Overall Number of Participants Analyzed 8 8
Median (Inter-Quartile Range)
Unit of Measure: m/s
Baseline Number Analyzed 8 participants 8 participants
.22
(.08 to .32)
.23
(.07 to .36)
Gait speed change 30 days Number Analyzed 8 participants 8 participants
0.330
(0.049 to 0.498)
0.193
(0.000 to 0.590)
Gait speed change 90 days Number Analyzed 8 participants 8 participants
0.385
(0.030 to 0.635)
0.165
(0.000 to 0.760)
BL Ambulatory: Gait Speed 30 days Number Analyzed 6 participants 7 participants
0.591
(0.180 to 0.910)
0.575
(0.326 to 1.060)
BL Ambulatory: Gait Speed 90 days Number Analyzed 4 participants 5 participants
0.572
(0.275 to 0.942)
0.406
(0.240 to 1.220)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments This was a descriptive analysis for a pilot study to gather preliminary data for a larger trial. No power calculations were performed for this outcome.
Statistical Test of Hypothesis P-Value .9581
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments The null hypothesis was assumed, and no power calculation was performed since this was a pilot study and the purpose was to collect preliminary data for a larger trial.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .6678
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Cerebral Perfusion Imaging
Hide Description Participants from each group who had an MRI at baseline will be randomly selected to have a repeat MRI perfusion scan at 30 days. Cerebral blood flow will be measured by MRI perfusion scanning (arterial spin labeling) in the region of the stroke.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
MRI cerebral perfusion data could not be analyzed because of a change in the measurement of perfusion after the first participant was enrolled.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Upper Extremity Grip Strength
Hide Description The hand grip strength test is designed to replicate the grip strength required to undertake officer survival and firearms training. The test is completed using a dynamometer which measures grip strength in kilograms (kg). The score ranges from 0-90kg, higher score denotes better outcomes.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only 6 participants in each group had grip strength measured at 30 days. Affected refers to the upper extremity that was affected by the stroke, and unaffected refers to the upper extremity not affected by the stroke.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Overall Number of Participants Analyzed 6 6
Mean (Inter-Quartile Range)
Unit of Measure: kg
Affected
17.4
(11.5 to 32.5)
20
(11 to 35)
Unaffected
28.75
(22 to 49.4)
34.75
(21.5 to 38.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .876
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Upper Extremity Grip Strength
Hide Description The hand grip strength test is designed to replicate the grip strength required to undertake officer survival and firearms training. The test is completed using a dynamometer which measures grip strength in kilograms. The score ranges from 0-90kg, higher score denotes better outcomes.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only 6 in the active and 7 in the placebo had grip strength measured at 90 days. Affected refers to the upper extremity that was affected by the stroke, and unaffected refers to the upper extremity not affected by the stroke.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Overall Number of Participants Analyzed 6 7
Mean (Inter-Quartile Range)
Unit of Measure: kg
Affected
17.5
(8 to 22.7)
11
(3 to 27)
Unaffected
26.75
(19.5 to 31.3)
33
(23 to 85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .889
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.532
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Montreal Cognitive Assessment (MoCA) Score
Hide Description Cognition is measured with the Montreal Cognitive Assessment. MoCA is a 30 question test that assesses different types of cognitive abilities, including orientation, short-term memory, executive function, language abilities, attention and visuospatial ability. Scores on the MoCA range from zero to 30, higher scores denotes better outcomes.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 participants in the active and 8 in the placebo were able to complete the MoCA at 30 days.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Overall Number of Participants Analyzed 5 8
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
23.5
(19 to 27)
23
(20 to 25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.888
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Montreal Cognitive Assessment (MoCA) Score
Hide Description Cognition is measured with the Montreal Cognitive Assessment. Cognition is measured with the Montreal Cognitive Assessment. MoCA is a 30 question test that assesses different types of cognitive abilities, including orientation, short-term memory, executive function, language abilities, attention and visuospatial ability. Scores on the MoCA range from zero to 30, higher scores denotes better outcomes.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only 5 participants in the active and 8 in the placebo were able to complete the MoCA at 90 days.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Overall Number of Participants Analyzed 5 8
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
27
(24 to 29)
23.5
(19.5 to 26.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Modified Rankin Score
Hide Description Modified Rankin Scale is a measure of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scores range from 0 (no symptoms) to 5 (bedridden in a nursing home). Lower scores denotes better outcomes.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only 8 participants in the active and 8 in the placebo returned for the 30 day visit in order to measure the modified Rankin score.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Overall Number of Participants Analyzed 8 8
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
3
(1 to 3)
3
(2 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.135
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Modified Rankin Score
Hide Description Modified Rankin Scale is a measure of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scores range from 0 (no symptoms) to 5 (bedridden in a nursing home). Lower scores denotes better outcomes.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only 6 participants in the active and 8 in the placebo returned for the 90 day visit and therefore modified Rankin could not be ascertained.
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description:

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

Overall Number of Participants Analyzed 6 8
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
2.5
(1 to 3)
3
(2.5 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Beet It Beetroot Juice, Beet It Beetroot Juice Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.185
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Hide Arm/Group Description

70 cc (3.8 millimoles nitrate) Beet It organic beetroot juice once a day for 30 days. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.

Beet it Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle

70 cc Beet It organic beetroot juice (placebo) once a day for 30 days. The placebo beet juice is identical in appearance and taste with nitrate removed. Vitamin C 500 mg (tablets) will be given along with each dose of the juice.Beet It Placebo Beetroot juice.

Beet It Placebo Beetroot juice: Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.

All-Cause Mortality
Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/9 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      0/9 (0.00%)    
Endocrine disorders     
Hypoglycemia   1/9 (11.11%)  1 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Beet It Beetroot Juice Beet It Beetroot Juice Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/9 (55.56%)      3/9 (33.33%)    
Blood and lymphatic system disorders     
Easy bruising   1/9 (11.11%)  1 0/9 (0.00%)  0
Cardiac disorders     
Hypotension  2/9 (22.22%)  3 0/9 (0.00%)  0
Non-specific SA nodal disease   0/9 (0.00%)  0 1/9 (11.11%)  1
Endocrine disorders     
Hypothermia   1/9 (11.11%)  1 0/9 (0.00%)  0
Hyperkalemia   1/9 (11.11%)  1 0/9 (0.00%)  0
Eye disorders     
Eye floater   0/9 (0.00%)  0 1/9 (11.11%)  2
Gastrointestinal disorders     
Nausea   2/9 (22.22%)  3 0/9 (0.00%)  0
Gastroesophageal refluix   2/9 (22.22%)  2 1/9 (11.11%)  1
Diarrhea   2/9 (22.22%)  2 0/9 (0.00%)  0
Constipation   1/9 (11.11%)  1 2/9 (22.22%)  3
Emesis   2/9 (22.22%)  2 0/9 (0.00%)  0
Blood in stool   0/9 (0.00%)  0 1/9 (11.11%)  1
General disorders     
Dysphagia   0/9 (0.00%)  0 1/9 (11.11%)  2
Fall   0/9 (0.00%)  0 1/9 (11.11%)  1
Infections and infestations     
Urinary tract infection   1/9 (11.11%)  2 0/9 (0.00%)  0
Nervous system disorders     
Stroke   1/9 (11.11%)  1 1/1 (100.00%)  1
Seizure   1/9 (11.11%)  1 0/9 (0.00%)  0
Mental alteration   1/9 (11.11%)  1 0/9 (0.00%)  0
Dizziness *  2/9 (22.22%)  3 0/9 (0.00%)  0
Headache   0/9 (0.00%)  0 1/9 (11.11%)  2
Reproductive system and breast disorders     
Chest Pain   1/9 (11.11%)  1 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Shortness of Breath   2/9 (22.22%)  2 0/9 (0.00%)  0
Pneumonia   1/9 (11.11%)  1 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Cheryl Bushnell
Organization: Wake Forest School of Medicine
Phone: 336-716-4101
EMail: cbushnel@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02838901     History of Changes
Other Study ID Numbers: IRB00020739
First Submitted: June 19, 2016
First Posted: July 20, 2016
Results First Submitted: September 6, 2017
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018