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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Omega-3 Fatty Acids for Treating Adults With Major Depression

NCT00517036

Depression

COMPLETED PHASE3

A Study of Omega-3 as a Treatment for Major Depression

NCT00238758

Major Depression Dysthymia

UNKNOWN PHASE2

Omega-3 Unsaturated Fatty Acid Improves Cognitive Function in Patients With Depression

NCT04803071

Cognitive Impairment Depression

UNKNOWN NA

Omega-3 Fatty Acids and/or Multi-domain Intervention in the Prevention of Age-related Cognitive Decline

NCT00672685

Frail Elderly Subjects

COMPLETED NA

Omega-3 Polyunsaturated Fatty Acids on Major Depressive Disorder in Patients With Cardiovascular Diseases

NCT03072823

Cardiovascular Diseases Major Depressive Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognitive Impairment Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High Oleic Sunflower Oil

Group Type PLACEBO_COMPARATOR

n-3 Fatty Acid Supplementation

Intervention Type BEHAVIORAL

400 mg EPA+DHA/day

low dose fish oil

Group Type ACTIVE_COMPARATOR

n-3 Fatty Acid Supplementation

Intervention Type BEHAVIORAL

1800 mg EPA+DHA/day

high dose fish oil

Group Type ACTIVE_COMPARATOR

n-3 Fatty Acid Supplementation

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

n-3 Fatty Acid Supplementation

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes