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

January 11, 2011 updated by: ZonMw: The Netherlands Organisation for Health Research and Development

The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People: a Double-blind Placebo-controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Wageningen, Gelderland, Netherlands, 6700 EV
        • Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women
  • Aged 65 years and over
  • Informed consent signed

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 4 times 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 the trial or at the same time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: High Oleic Sunflower Oil
Behavioral: n-3 Fatty Acid Supplementation
Active Comparator: 400 mg EPA+DHA/day
low dose fish oil
Behavioral: n-3 Fatty Acid Supplementation
Active Comparator: 1800 mg EPA+DHA/day
high dose fish oil
Behavioral: n-3 Fatty Acid Supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cognitive function
Depression

Secondary Outcome Measures

Outcome Measure
Quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Study Director: Lisette de Groot, Dr Ir, Project leader
  • Study Director: Marianne Geleijnse, Dr, Project leader

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

July 26, 2005

First Submitted That Met QC Criteria

July 26, 2005

First Posted (Estimate)

July 28, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2011

Last Update Submitted That Met QC Criteria

January 11, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005_05/08
  • 6100.0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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