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| Name | Class |
|---|---|
| Department of Health, Executive Yuan, R.O.C. (Taiwan) | OTHER_GOV |
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This preliminary study is aimed to investigate whether it is feasible to conduct a study to use fish oil compared to the placebo(olive oil) in people with cognitive impairment. We will also explore whether fish oil has better efficacy in some clinical aspects in people with cognitive impairment during 24 weeks intervention. The major clinical outcome will be:
Despite some positive findings from observational and animal studies, the effects of n-3 PUFA administration on cognitive impairment in humans have received little evaluation to date. Although some clinical trials of fish oil have been reported, the results are inconsistent. Given these inconsistent findings, we carried out a preliminary study to investigate the effect of fish oil monotherapy on cognitive function and general clinical condition in patients with cognitive impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | omega-3 PUFAs(180mg eicosapentaenoic acid[EPA] + 120mg docosahexaenoic acid[DHA]/capsule), 3 capsules twice daily, total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA |
|
| 2 | Placebo Comparator | three identical placebo capsules twice daily which contained olive oil esters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 polyunsaturated fatty acids ( EPA+DHA) | Dietary Supplement | Group 1 received omega-3 PUFAs as 3 capsules twice daily (total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA). Group 2 received three identical placebo capsules twice daily which contained olive oil esters. Identical gelatin capsules were used. Both treatment and placebo capsules were vacuum deodorized and supplemented with tertiary-butyl hydroquinone, 0.2 mg/g, and tocopherols, 2 mg/g, as antioxidants. The source of the omega-3 fatty acids was menhaden fish body oil concentrate. |
| Measure | Description | Time Frame |
|---|---|---|
| the Clinician's Interview-Based Impression of Change Scale (CIBIC-plus) | 24 weeks | |
| the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mini Mental Status Examination (MMSE) scores | 24 weeks | |
| 17-item Hamilton Depression Scale (HDRS) | 24 weeks | |
| adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chih-Chiang Chiu, M.D. | Department of Psychiatry, Taipei Psychiatric Center, Taipei City Hospital, Taipei, Taiwan | Principal Investigator |
| Shih-Yi Huang, PhD. | School of Nutrition and Health Sciences, Taipei Medical University, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei City Psychiatric Center, Taipei City Hospital | Taipei | 110 | Taiwan |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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|
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| 24 weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |