Preliminary Study of Fish Oil and Dementia

NCT00628017 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2008-03-04

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Department of Health, Executive Yuan, R.O.C. (Taiwan)

    collaborator OTHER_GOV
  • Taipei City Psychiatric Center, Taiwan

    lead OTHER

Principal Investigators

  • Chih-Chiang Chiu, M.D. · Department of Psychiatry, Taipei Psychiatric Center, Taipei City Hospital, Taipei, Taiwan

  • Shih-Yi Huang, PhD. · School of Nutrition and Health Sciences, Taipei Medical University, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2005-03-31
Completion
2005-03-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00628017 on ClinicalTrials.gov