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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01780974
First received: January 29, 2013
Last updated: February 22, 2017
Last verified: February 2017
Results First Received: December 20, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
Lipoic Acid Plus Omega-3 Fatty Acids Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate

Participant Flow:   Overall Study
    Placebo   Lipoic Acid Plus Omega-3 Fatty Acids
STARTED   21   21 
COMPLETED   19   18 
NOT COMPLETED   2   3 
Death                1                0 
Adverse Event                1                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
Lipoic Acid Plus Omega-3 Fatty Acids Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
Total Total of all reporting groups

Baseline Measures
   Placebo   Lipoic Acid Plus Omega-3 Fatty Acids   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   21   42 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 21   21   42 
   66.05  (8.19)   65.38  (5.84)   65.71  (7.03) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 21   21   42 
Female      17  81.0%      10  47.6%      27  64.3% 
Male      4  19.0%      11  52.4%      15  35.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 21   21   42 
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) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 21   21   42 
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 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 21   21   42 
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] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 20   20   40 
Yes      5  25.0%      7  35.0%      12  30.0% 
No      15  75.0%      13  65.0%      28  70.0% 
[1] Apo E data for 2 participants missing
Systolic BP 
[Units: mmHg]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 21   21   42 
   131.76  (15.77)   141.67  (14.64)   136.71  (15.84) 
Diastolic BP 
[Units: mmHg]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 21   21   42 
   74.29  (10.79)   77.05  (9.76)   75.67  (10.26) 
Exercise [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 19   20   39 
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] Demographic information form missing for 3 participants
Smoking [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 20   20   40 
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] Demographic information missing for 2 participants
Arachidonic Acid (AA) 
[Units: % composition of blood]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 21   21   42 
   9.33  (1.40)   10.64  (1.56)   9.98  (1.61) 
Eicosapentaenoic Acid (EPA) 
[Units: % composition of blood]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 21   21   42 
   0.84  (0.41)   0.62  (0.19)   0.73  (0.33) 
Docosahexaenoic Acid (DHA) 
[Units: % composition of blood]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 21   21   42 
   2.62  (1.01)   2.53  (0.59)   2.58  (0.82) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Trails Making Test Part B (Executive Function)   [ Time Frame: Baseline, 6 months, and 12 months ]

2.  Secondary:   White Matter Hyperintensity Volume (Brain MRI)   [ Time Frame: Baseline and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No Omega-3 only or lipoic acid only arm; not excluding over-the-counter medications and supplements


  More Information
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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
e-mail: shintol@ohsu.edu



Responsible Party: Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01780974     History of Changes
Other Study ID Numbers: SFF01
Study First Received: January 29, 2013
Results First Received: December 20, 2016
Last Updated: February 22, 2017