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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cognitive Impairment, Depression

Intervention / Treatment
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* Behavioral: n-3 Fatty Acid Supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function |  |  | 
| Depression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognition, depression, elderly