The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People

Last updated: January 11, 2011
Sponsor: ZonMw: The Netherlands Organisation for Health Research and Development
Overall Status: Completed

Phase

N/A

Condition

Memory Loss

Dementia

Depression

Treatment

N/A

Clinical Study ID

NCT00124852
2005_05/08
6100.0004
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women

  • Aged 65 years and over

  • Informed consent signed

Exclusion

Exclusion Criteria:

  • A score of > 16 on the CES-D (Centre for Epidemiological Studies-Depression Scale

  • A score of < 21 points on MMSE (Mini-Mental State Examination)

  • Current or recent (<4 weeks) use of fish oil supplements or intake of more than 4times fish as judged by a fish consumption questionnaire

  • Current use of pharmacological antidepressants

  • Current use of dementia (Alzheimer) medication

  • Serious liver disease

  • Use of more than 4 glasses of alcohol per day

  • Unable to participate as judged by the responsible medical physician

  • Allergy to fish(oil)

  • Swallowing problems

  • Participation in another clinical trial less than 2 months before the start of thetrial or at the same time

Study Design

Total Participants: 302
Study Start date:
October 01, 2005
Estimated Completion Date:
July 31, 2007

Study Description

The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures. In this study 300 elderly people will be randomly allocated to one of three treatments. Two groups will receive fish oil capsules with different doses EPA/DHA (a normal dose or a high dose) and the third group will receive placebo capsules. At the start and at the end of the intervention period cognitive function, the occurrence of depression, quality of life, anthropometric values and biochemical indicators will be measured.

After completion of the trial a workshop will be organized in which the outcomes of the proposed study will be presented to representatives of several key areas concerning mental health of elderly people.

Connect with a study center

  • Wageningen University

    Wageningen, Gelderland 6700 EV
    Netherlands

    Site Not Available

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