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Pilot Study: Lipoic Acid and Omega-3 Fatty Acids for Alzheimer's Prevention

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: NCT01780974
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Treated Hypertension
Interventions Drug: Lipoic Acid plus Omega-3 Fatty Acids
Drug: Placebo
Enrollment 42
Recruitment Details  
Pre-assignment Details Med exclusions included Omega-3 fatty acid supplement intake < 4 months prior to enrollment; Lipoic acid supplementation < 1 month prior to enrollment; stable dosage for 4 months prior to enrollment of antihypertensive medication and (if prescribed) lipid lowering medication. Other exclusions included labs and test scores out of range.
Arm/Group Title Placebo Lipoic Acid Plus Omega-3 Fatty Acids
Hide Arm/Group Description Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
Period Title: Overall Study
Started 21 21
Completed 19 18
Not Completed 2 3
Reason Not Completed
Death             1             0
Adverse Event             1             3
Arm/Group Title Placebo Lipoic Acid Plus Omega-3 Fatty Acids Total
Hide Arm/Group Description Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
66.05  (8.19) 65.38  (5.84) 65.71  (7.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
17
  81.0%
10
  47.6%
27
  64.3%
Male
4
  19.0%
11
  52.4%
15
  35.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Hispanic or Latino
1
   4.8%
2
   9.5%
3
   7.1%
Not Hispanic or Latino
20
  95.2%
19
  90.5%
39
  92.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.8%
1
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   4.8%
1
   2.4%
White
20
  95.2%
18
  85.7%
38
  90.5%
More than one race
0
   0.0%
1
   4.8%
1
   2.4%
Unknown or Not Reported
1
   4.8%
0
   0.0%
1
   2.4%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
High school or less
4
  19.0%
1
   4.8%
5
  11.9%
Some college
2
   9.5%
2
   9.5%
4
   9.5%
Completed college
5
  23.8%
7
  33.3%
12
  28.6%
Masters/Graduate School
10
  47.6%
11
  52.4%
21
  50.0%
Apo E4 Carrier   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Yes
5
  25.0%
7
  35.0%
12
  30.0%
No
15
  75.0%
13
  65.0%
28
  70.0%
[1]
Measure Analysis Population Description: Apo E data for 2 participants missing
Systolic BP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 21 participants 21 participants 42 participants
131.76  (15.77) 141.67  (14.64) 136.71  (15.84)
Diastolic BP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 21 participants 21 participants 42 participants
74.29  (10.79) 77.05  (9.76) 75.67  (10.26)
Exercise   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Doesn't exercise
3
  15.8%
2
  10.0%
5
  12.8%
Some exercise
2
  10.5%
3
  15.0%
5
  12.8%
Exercises 2+ times/week
14
  73.7%
15
  75.0%
29
  74.4%
[1]
Measure Analysis Population Description: Demographic information form missing for 3 participants
Smoking   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Non-smoker
10
  50.0%
11
  55.0%
21
  52.5%
Former smoker
10
  50.0%
9
  45.0%
19
  47.5%
Smoker
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Demographic information missing for 2 participants
Arachidonic Acid (AA)  
Mean (Standard Deviation)
Unit of measure:  % composition of blood
Number Analyzed 21 participants 21 participants 42 participants
9.33  (1.40) 10.64  (1.56) 9.98  (1.61)
Eicosapentaenoic Acid (EPA)  
Mean (Standard Deviation)
Unit of measure:  % composition of blood
Number Analyzed 21 participants 21 participants 42 participants
0.84  (0.41) 0.62  (0.19) 0.73  (0.33)
Docosahexaenoic Acid (DHA)  
Mean (Standard Deviation)
Unit of measure:  % composition of blood
Number Analyzed 21 participants 21 participants 42 participants
2.62  (1.01) 2.53  (0.59) 2.58  (0.82)
1.Primary Outcome
Title Trails Making Test Part B (Executive Function)
Hide Description The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Time Frame Baseline, 6 months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Not all tests were completed by all randomized subjects due to missed visits and/or discontinuations.
Arm/Group Title Placebo Lipoic Acid Plus Omega-3 Fatty Acids
Hide Arm/Group Description:

Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal.

Placebo: placebo capsules

Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal.

Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate

Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: time to completion (seconds)
Baseline Number Analyzed 21 participants 21 participants
69.57  (19.15) 81.59  (53.08)
6 Months Number Analyzed 20 participants 18 participants
62.53  (16.59) 69.25  (20.55)
12 Months Number Analyzed 18 participants 17 participants
69.75  (20.79) 71.10  (32.77)
2.Secondary Outcome
Title White Matter Hyperintensity Volume (Brain MRI)
Hide Description [Not Specified]
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
At baseline, 4 participants either could not complete the MRI or the MRI could not be analyzed due to quality; at 12 months, 13 participants either discontinued, could not complete the MRI, or did not complete the baseline and therefore were not scanned.
Arm/Group Title Placebo Lipoic Acid Plus Omega-3 Fatty Acids
Hide Arm/Group Description:

Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal.

Placebo: placebo capsules

Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal.

Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate

Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: cubic centimeters
Baseline Number Analyzed 19 participants 19 participants
6.13  (11.91) 5.31  (7.37)
12 Months Number Analyzed 15 participants 14 participants
5.14  (13.04) 5.07  (7.01)
Time Frame From baseline to 12 months (end of treatment)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Lipoic Acid Plus Omega-3 Fatty Acids
Hide Arm/Group Description placebo capsules Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
All-Cause Mortality
Placebo Lipoic Acid Plus Omega-3 Fatty Acids
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Lipoic Acid Plus Omega-3 Fatty Acids
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/21 (14.29%)      1/21 (4.76%)    
Cardiac disorders     
Severe angina with worsening symptoms  2 [1]  0/21 (0.00%)  0 1/21 (4.76%)  1
Death from unknown cardiac event  4 [2]  1/21 (4.76%)  1 0/21 (0.00%)  0
Nervous system disorders     
Benign peripheral position vertigo requiring hospitalization  1 [3]  1/21 (4.76%)  1 0/21 (0.00%)  0
Psychiatric disorders     
Suicide attempt  3 [4]  1/21 (4.76%)  1 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Vertigo positional
2
Term from vocabulary, Angina unstable
3
Term from vocabulary, Suicide attempt
4
Term from vocabulary, Cardiac death
[1]
Severe angina with worsening symptoms, hospitalized and admitted for coronary bypass surgery
[2]
Death from cardiac event
[3]
Hospitalized overnight with diagnosis of benign peripheral positional vertigo
[4]
Hospitalized after suicide attempt
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Lipoic Acid Plus Omega-3 Fatty Acids
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/21 (76.19%)      17/21 (80.95%)    
Gastrointestinal disorders     
Gastrooesophageal reflux disease   2/21 (9.52%)  4/21 (19.05%) 
Dyspepsia   0/21 (0.00%)  7/21 (33.33%) 
Supplement-related difficulties  [1]  0/21 (0.00%)  2/21 (9.52%) 
Vomiting   2/21 (9.52%)  2/21 (9.52%) 
Nausea   1/21 (4.76%)  3/21 (14.29%) 
General disorders     
Fatigue   0/21 (0.00%)  2/21 (9.52%) 
Injury, poisoning and procedural complications     
Fall   2/21 (9.52%)  0/21 (0.00%) 
Accident-related injuries   5/21 (23.81%)  3/21 (14.29%) 
Musculoskeletal and connective tissue disorders     
Arm pain   1/21 (4.76%)  2/21 (9.52%) 
Back pain   2/21 (9.52%)  1/21 (4.76%) 
Psychiatric disorders     
Suicidal ideations & behaviors   2/21 (9.52%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory tract infection   3/21 (14.29%)  0/21 (0.00%) 
Surgical and medical procedures     
Surgery  [2]  5/21 (23.81%)  2/21 (9.52%) 
Vascular disorders     
Dizziness/Vertigo   1/21 (4.76%)  2/21 (9.52%) 
Indicates events were collected by systematic assessment
[1]
Expected side-effects from supplement (i.e., trouble swallowing, fish burps)
[2]
Surgeries for pre-existing conditions
No Omega-3 only or lipoic acid only arm; not excluding over-the-counter medications and supplements
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: Lynne Shinto, ND, MPH
Organization: Oregon Health & Science University
Phone: 503-494-5035
Responsible Party: Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01780974     History of Changes
Other Study ID Numbers: SFF01
First Submitted: January 29, 2013
First Posted: January 31, 2013
Results First Submitted: December 20, 2016
Results First Posted: April 7, 2017
Last Update Posted: April 7, 2017