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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG023805-01 | U.S. NIH Grant/Contract | View source | |
| 5R21AG023805-02 | U.S. NIH Grant/Contract | View source | |
| AG08017 | Other Grant/Funding Number | National Institute of Aging | |
| M01RR000334 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish Oil Placebo & Lipoic Acid Placebo | Placebo Comparator | 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. |
|
| Fish Oil Only | Active Comparator | 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. |
|
| Fish Oil Plus Lipoic Acid | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish Oil | Dietary Supplement | Fish oil capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| F2-isoprostane Level Urine F2-Isoprostanes | 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. | baseline, 12 months |
| Change in Mini-Mental State Exam (MMSE) Score From Baseline to 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. | baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynne H. Shinto, ND | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15339646 | Background | Calon F, Lim GP, Yang F, Morihara T, Teter B, Ubeda O, Rostaing P, Triller A, Salem N Jr, Ashe KH, Frautschy SA, Cole GM. Docosahexaenoic acid protects from dendritic pathology in an Alzheimer's disease mouse model. Neuron. 2004 Sep 2;43(5):633-45. doi: 10.1016/j.neuron.2004.08.013. | |
| 12873849 | Background | Morris MC, Evans DA, Bienias JL, Tangney CC, Bennett DA, Wilson RS, Aggarwal N, Schneider J. Consumption of fish and n-3 fatty acids and risk of incident Alzheimer disease. Arch Neurol. 2003 Jul;60(7):940-6. doi: 10.1001/archneur.60.7.940. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fish Oil | Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months. |
| FG001 | Placebo | Placebo oil (soybean oil), daily dose 3 grams taken for 12 months |
| FG002 | Fish Oil Plus Lipoic Acid | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo oil (soybean oil), daily dose 3 grams taken for 12 months |
| BG001 | Fish Oil | Fish oil concentrate, daily dose 3 grams per day containing 675 mg docosahexaenoic acid and 975 mg eicosapentanoic acid, taken for 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | F2-isoprostane Level Urine F2-Isoprostanes | 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. | intention to treat (ITT) | Posted | Mean | Standard Deviation | nanogram per miligram | baseline, 12 months |
|
12 months
Monthly subject report assessment; prothrombin time and comprehensive metabolic panel at baseline, 6 months, 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure | Cardiac disorders | SNOMED CT | Systematic Assessment | death from heart failure subject in fish oil group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Endocrine disorders | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynne Shinto, ND, MPH | Oregon Health & Science University | 503-494-5035 | shintol@ohsu.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D006949 | Hyperlipidemias |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| D015525 | Fatty Acids, Omega-3 |
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
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| Lipoic Acid | Dietary Supplement | Lipoic acid capsule |
|
|
| Fish Oil Placebo | Other | Soybean oil placebo capsule |
|
|
| Lipoic Acid Placebo | Other | Lipoic acid (LA) placebo capsule containing no LA |
|
|
| baseline, 12 months |
| 12897407 | Background | Lovell MA, Xie C, Xiong S, Markesbery WR. Protection against amyloid beta peptide and iron/hydrogen peroxide toxicity by alpha lipoic acid. J Alzheimers Dis. 2003 Jun;5(3):229-39. doi: 10.3233/jad-2003-5306. |
| 24077434 | Result | Shinto L, Quinn J, Montine T, Dodge HH, Woodward W, Baldauf-Wagner S, Waichunas D, Bumgarner L, Bourdette D, Silbert L, Kaye J. A randomized placebo-controlled pilot trial of omega-3 fatty acids and alpha lipoic acid in Alzheimer's disease. J Alzheimers Dis. 2014;38(1):111-20. doi: 10.3233/JAD-130722. |
| stopped taking study medication |
|
| BG002 | Fish Oil Plus Lipoic Acid | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Fish Oil Plus Lipoic Acid | 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. |
|
|
|
| Primary | Change in Mini-Mental State Exam (MMSE) Score From Baseline to 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 months |
|
|
|
| Secondary | Change in Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) Scores From Baseline to 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. | 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. | Posted | Mean | Standard Error | units on a scale | baseline, 12 months |
|
|
|
| 1 |
| 13 |
| 9 |
| 13 |
| EG001 | Fish Oil | 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. | 1 | 13 | 5 | 13 |
| EG002 | Fish Oil Plus Lipoic Acid | 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). | 0 | 13 | 7 | 13 |
|
| Urinary Tract Infection (UTI) | Renal and urinary disorders | SNOMED CT | Systematic Assessment | Death resulting from UTI complications in placebo group. |
|
| Falls | Nervous system disorders | SNOMED CT | Systematic Assessment |
|
| cold | General disorders | SNOMED CT | Systematic Assessment |
|
| loose stools | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
|
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| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005223 |
| Fats |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |