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

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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

  Participant Flow

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

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   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   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   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   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   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   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   21   21   42 
   131.76  (15.77)   141.67  (14.64)   136.71  (15.84) 
Diastolic BP 
[Units: mmHg]
Mean (Standard Deviation)
     
Participants Analyzed   21   21   42 
   74.29  (10.79)   77.05  (9.76)   75.67  (10.26) 
Exercise [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   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   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   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   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   21   21   42 
   2.62  (1.01)   2.53  (0.59)   2.58  (0.82) 


  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

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

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
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