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

ZonMw: The Netherlands Organisation for Health Research and Development

Status: Completed

Conditions: Cognitive Impairment; Depression

Treatments: Behavioral: n-3 Fatty Acid Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT00124852

2005_05/08

6100.0004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 302 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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302 participants in 3 patient groups, including a placebo group

High Oleic Sunflower Oil

Placebo Comparator group

Treatment:

Behavioral: n-3 Fatty Acid Supplementation

400 mg EPA+DHA/day

Active Comparator group

Description:

low dose fish oil

Treatment:

Behavioral: n-3 Fatty Acid Supplementation

1800 mg EPA+DHA/day

Active Comparator group

Description:

high dose fish oil

Treatment:

Behavioral: n-3 Fatty Acid Supplementation