NCT00628017

Preliminary Study of Fish Oil and Dementia

The Effects of Omega-3 Fatty Acids Monotherapy in Alzheimer's Disease and Mild Cognitive Impairment: a Preliminary Randomized Double-Blind Placebo-Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Taipei City Psychiatric Center, Taiwan · Academic / Other
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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: 1. general clinical impression 2. cognitive function

Detailed description

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.

Conditions

• Alzheimer's Disease
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	omega-3 polyunsaturated fatty acids ( EPA+DHA)	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.

Timeline

• Start date: 2003-01-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2008-03-04
• Last updated: 2008-03-04

Locations

1 site across 1 country: Taiwan