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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00090402
First received: August 25, 2004
Last updated: June 21, 2017
Last verified: June 2017
  Purpose
The purpose of this study is to determine the effect of fish oil and the antioxidant alpha lipoic acid on factors in the blood that are associated with the progression of Alzheimer's Disease (AD).

Condition Intervention Phase
Alzheimer's Disease Oxidative Stress Dementia Hyperlipidemia Inflammation Dietary Supplement: Fish Oil Dietary Supplement: Lipoic Acid Other: Fish Oil Placebo Other: Lipoic Acid Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: Fish Oil and Alpha Lipoic Acid in Mild Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Lynne Shinto, Oregon Health and Science University:

Primary Outcome Measures:
  • F2-isoprostane Level Urine F2-Isoprostanes [ Time Frame: baseline, 12 months ]
    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.

  • Change in Mini-Mental State Exam (MMSE) Score From Baseline to 12 Months [ Time Frame: baseline, 12 months ]
    The MMSE is a measure of global cognitive function, and scores range from 0-30, with a lower score indicates greater cognitive impairment.


Secondary Outcome Measures:
  • Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 12 Months [ Time Frame: baseline, 12 months ]
    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.


Enrollment: 39
Actual Study Start Date: April 2004
Study Completion Date: August 2007
Primary Completion Date: January 3, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Fish Oil Placebo & Lipoic Acid Placebo
Three 1-gram placebo-fish oil capsules (2 in the morning, 1 evening) plus one 600 milligram placebo-lipoic acid per day. Placebo fish oil capsules consisted of soybean oil flavored with lemon flavor and 5% fish oil to match fish oil capsules. LA placebo contained no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate.
Other: Fish Oil Placebo
Soybean oil placebo capsule
Other Name: Placebo (for fish oil)
Other: Lipoic Acid Placebo
Lipoic acid (LA) placebo capsule containing no LA
Other Name: Placebo (for lipoic acid)
Active Comparator: Fish Oil Only
Three 1-gram fish oil concentrate capsules in triglyceride form (675 milligrams DHA and 975 milligrams EPA), 2 in the morning and 1 in the evening, plus one 600 milligram placebo-lipoic acid (containing no LA and the following excipients: lactose, hypromellose, silicon dioxide, microcrystalline cellulose, polyethylene glycol, povidone, corn starch, talc, and magnesium stearate) per day.
Dietary Supplement: Fish Oil
Fish oil capsule
Other Name: Fish oil concentrate, omega-3 fatty acids
Other: Lipoic Acid Placebo
Lipoic acid (LA) placebo capsule containing no LA
Other Name: Placebo (for lipoic acid)
Experimental: Fish Oil Plus Lipoic Acid
Three 1-gram placebo-fish oil capsules (2 in the morning, 1 evening) plus one 600 milligram lipoic acid (LA) capsule in the racemic form per day.
Dietary Supplement: Fish Oil
Fish oil capsule
Other Name: Fish oil concentrate, omega-3 fatty acids
Dietary Supplement: Lipoic Acid
Lipoic acid capsule
Other Name: thiotic acid, alpha lipoic acid

Detailed Description:

Alzheimer's disease (AD) is a serious condition associated with increased inflammation, cholesterol, and oxidative stress (a condition involving an excess of free radicals and a decrease in antioxidant levels). Fish oil and alpha lipoic acid, which have few side effects, may help relieve these problems; therefore, these supplements may slow the progression of AD, particularly when given in combination. This study will evaluate the effect of fish oil and alpha lipoic acid on inflammation, lipid levels, and oxidative stress.

Participants in this study will be randomly assigned to receive fish oil alone, fish oil and alpha lipoic acid, or placebo for 1 year. AD rating scales as well as urine and blood tests will be used to assess participants. Participants will have monthly clinic visits during the study to monitor adverse events and to undergo various laboratory tests.

  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease or mild cognitive impairment
  • Mini Mental State Examination (MMSE) score between 18 and 26
  • Clinical Dementia Rating (CDR) of 0.5 or 1.0
  • Fluent in English

Exclusion Criteria:

  • Use of lipid lowering medications
  • Consumption of fish of more than twice a week
  • Use of omega and alpha lipoic acid supplements
  • Use of systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, or narcotic analgesics
  • Depression
  • Any other serious health conditions that may interfere with the study
  • Enrollment in another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090402

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institute on Aging (NIA)
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Lynne H. Shinto, ND Oregon Health and Science University
  More Information

Publications:
Responsible Party: Lynne Shinto, ND, MPH, 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 )
Study First Received: August 25, 2004
Results First Received: December 2, 2009
Last Updated: June 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lynne Shinto, Oregon Health and Science University:
Fish Oils
Thioctic Acid
Antioxidants
Dietary Supplements

Additional relevant MeSH terms:
Alzheimer Disease
Thioctic Acid
Inflammation
Dementia
Hyperlipidemias
Hyperlipoproteinemias
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 21, 2017