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Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00090402
Recruitment Status : Completed
First Posted : August 26, 2004
Results First Posted : February 26, 2010
Last Update Posted : July 21, 2017
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Center for Research Resources (NCRR)
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, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Alzheimer's Disease
Oxidative Stress
Dementia
Hyperlipidemia
Inflammation
Interventions Dietary Supplement: Fish Oil
Dietary Supplement: Lipoic Acid
Other: Fish Oil Placebo
Other: Lipoic Acid Placebo
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fish Oil Placebo Fish Oil Plus Lipoic Acid
Hide Arm/Group Description Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months. Placebo oil (soybean oil), daily dose 3 grams taken for 12 months Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
Period Title: Overall Study
Started 13 13 13
Completed 11 11 12
Not Completed 2 2 1
Reason Not Completed
Death             1             1             0
subject moved             0             1             0
stopped taking study medication             1             0             1
Arm/Group Title Placebo Fish Oil Fish Oil Plus Lipoic Acid Total
Hide Arm/Group Description Placebo oil (soybean oil), daily dose 3 grams taken for 12 months Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months. Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months. Total of all reporting groups
Overall Number of Baseline Participants 13 13 13 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 13 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  15.4%
1
   7.7%
3
  23.1%
6
  15.4%
>=65 years
11
  84.6%
12
  92.3%
10
  76.9%
33
  84.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 13 participants 39 participants
75.2  (10.8) 75.9  (8.1) 76.7  (10.6) 75.9  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 13 participants 39 participants
Female
7
  53.8%
8
  61.5%
6
  46.2%
21
  53.8%
Male
6
  46.2%
5
  38.5%
7
  53.8%
18
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 13 participants 39 participants
13 13 13 39
1.Primary Outcome
Title F2-isoprostane Level Urine F2-Isoprostanes
Hide Description F2-isoprostane is a biomarker was used as an effective indicator for detecting a decrease in systemic oxidative damage (oxidative damage in lipids). Urine F2-Isoprostanes were used to avoid ex vivo lipid peroxidation that can occur with plasma samples.
Time Frame baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Placebo Fish Oil Fish Oil Plus Lipoic Acid
Hide Arm/Group Description:
Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
Overall Number of Participants Analyzed 13 13 13
Mean (Standard Deviation)
Unit of Measure: nanogram per miligram
0.40  (1.10) -2.02  (3.30) 0.45  (0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fish Oil, Fish Oil Plus Lipoic Acid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for age and body mass index
2.Primary Outcome
Title Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months
Hide Description The MMSE is a measure of global cognitive function, and scores range from 0–30, with a lower score indicates greater cognitive impairment.
Time Frame baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fish Oil Fish Oil Plus Lipoic Acid
Hide Arm/Group Description:
Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
Overall Number of Participants Analyzed 11 11 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.64  (4.65) -4.27  (4.15) -1.00  (2.30)
3.Secondary Outcome
Title Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months
Hide Description The Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) measures an individual's ability to carry out tasks that are important for daily living and capture functional changes. Scores for each question range from 0 (no assistance needed) to 2 (full assistance needed), and were assessed by informant interview. The combination of scores for ADL (ranging from 0-18) and IADL (0-14) is the outcome (0-32), with higher scores indicating lesser ability to carry out daily living tasks.
Time Frame baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
In the placebo group there were 2 discontinuations (1 moved, 1 death). In the fish oil group there were 2 discontinuations (1 discontinue, 1 death). In the fish oil and lipoic acid group there was 1 discontinuation (due to meds). These discontinuations did not complete the study.
Arm/Group Title Placebo Fish Oil Fish Oil and Lipoic Acid
Hide Arm/Group Description:

Three 1-gram placebo-fish oil capsule per day and 1 placebo-lipoic acid (LA) capsule per day (600 mg). Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil concentrate. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.

Placebo: Soybean oil 3 grams a day and placebo lipoic acid 600 milligrams a day taken for 12 months.

Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 placebo-lipoic acid (LA) capsule (600 mg) per day. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.

Fish Oil: Fish oil concentrate (daily dose 3 grams containing 675 milligrams docosahexanoic acid and 975 milligrams eicosapentanoic acid) taken for 12 months.

Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 lipoic acid (LA) capsule in the racemic form per day (600 mg).

Fish Oil and Lipoic acid: Fish oil concentrate(daily dose 3 grams containing 675 milligrams docosahexanoic acid and 975 milligrams eicosapentanoic acid) plus lipoic acid (daily dose 600 milligrams)taken for 12 months

Overall Number of Participants Analyzed 11 11 12
Mean (Standard Error)
Unit of Measure: units on a scale
4.2  (0.9) 0.7  (1.0) 0.9  (1.1)
Time Frame 12 months
Adverse Event Reporting Description Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
 
Arm/Group Title Placebo Fish Oil Fish Oil Plus Lipoic Acid
Hide Arm/Group Description Three 1-gram placebo-fish oil capsule per day and 1 placebo-lipoic acid (LA) capsule per day (600 mg). Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil concentrate. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 placebo-lipoic acid (LA) capsule (600 mg) per day. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate. Three 1-gram fish oil concentrate capsules in triglyceride form per day (675 mg DHA and 975 mg EPA) and 1 lipoic acid (LA) capsule in the racemic form per day (600 mg).
All-Cause Mortality
Placebo Fish Oil Fish Oil Plus Lipoic Acid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Fish Oil Fish Oil Plus Lipoic Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      1/13 (7.69%)      0/13 (0.00%)    
Cardiac disorders       
Heart Failure  1 [1]  0/13 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0
Renal and urinary disorders       
Urinary Tract Infection (UTI)  1 [2]  1/13 (7.69%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, SNOMED CT
[1]
death from heart failure subject in fish oil group
[2]
Death resulting from UTI complications in placebo group.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Fish Oil Fish Oil Plus Lipoic Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/13 (69.23%)      5/13 (38.46%)      7/13 (53.85%)    
Endocrine disorders       
Dizziness  1  1/13 (7.69%)  1 2/13 (15.38%)  2 2/13 (15.38%)  2
Gastrointestinal disorders       
loose stools  1  3/13 (23.08%)  3 0/13 (0.00%)  0 3/13 (23.08%)  3
General disorders       
cold  1  3/13 (23.08%)  3 2/13 (15.38%)  2 2/13 (15.38%)  2
Nervous system disorders       
Falls  1  2/13 (15.38%)  2 1/13 (7.69%)  1 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, SNOMED CT
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: Lynne Shinto, ND, MPH
Organization: Oregon Health & Science University
Phone: 503-494-5035
EMail: shintol@ohsu.edu
Layout table for additonal information
Responsible Party: Lynne Shinto, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00090402     History of Changes
Other Study ID Numbers: IA0062
1R21AG023805-01 ( U.S. NIH Grant/Contract )
5R21AG023805-02 ( U.S. NIH Grant/Contract )
AG08017 ( Other Grant/Funding Number: National Institute of Aging )
M01RR000334 ( U.S. NIH Grant/Contract )
First Submitted: August 25, 2004
First Posted: August 26, 2004
Results First Submitted: December 2, 2009
Results First Posted: February 26, 2010
Last Update Posted: July 21, 2017