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

Not Applicable

Completed

• Conditions: Cognitive Impairment; Depression
• Interventions: Behavioral: n-3 Fatty Acid Supplementation

• Registration Number: NCT00124852
• Lead Sponsor: ZonMw: The Netherlands Organisation for Health Research and Development

Brief 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.

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 Timeline

• Study First Submitted: 2005-07-26
• Study First Submitted QC: 2005-07-26
• Study First Posted: 2005-07-28
• Study Start: 2005-10
• Primary Completion: 2006-12
• Study Completion: 2007-07
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-11
• Last Update Posted: 2011-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Oleic Sunflower Oil	n-3 Fatty Acid Supplementation	-
400 mg EPA+DHA/day	n-3 Fatty Acid Supplementation	low dose fish oil
1800 mg EPA+DHA/day	n-3 Fatty Acid Supplementation	high dose fish oil

Primary Outcome Measures

Name	Time	Method
Cognitive function
Depression

Secondary Outcome Measures

Name	Time	Method
Quality of life

Trial Locations

Locations (1)

Wageningen University; 🇳🇱 Wageningen, Gelderland, Netherlands