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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124852
• Other study ID #: 2005_05/08
• Secondary ID: 6100.0004
• Status: Completed
• Phase: N/A
• First received: July 26, 2005
• Last updated: January 11, 2011
• Start date: October 2005
• Est. completion date: July 2007

Study information

• Verified date: January 2011
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: July 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Depression

Intervention

Behavioral:
• n-3 Fatty Acid Supplementation

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function
Primary	Depression
Secondary	Quality of life