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

This study has been completed.
Sponsor:
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00124852
First received: July 26, 2005
Last updated: January 11, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Cognitive Impairment
Depression
Behavioral: n-3 Fatty Acid Supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People: a Double-blind Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Cognitive function
  • Depression

Secondary Outcome Measures:
  • Quality of life

Enrollment: 302
Study Start Date: October 2005
Study Completion Date: July 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: High Oleic Sunflower Oil Behavioral: n-3 Fatty Acid Supplementation
Active Comparator: 400 mg EPA+DHA/day
low dose fish oil
Behavioral: n-3 Fatty Acid Supplementation
Active Comparator: 1800 mg EPA+DHA/day
high dose fish oil
Behavioral: n-3 Fatty Acid Supplementation

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124852

Locations
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV
Sponsors and Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: Lisette de Groot, Dr Ir Project leader
Study Director: Marianne Geleijnse, Dr Project leader
  More Information

No publications provided by Wageningen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Dr Lisette CPGM de Groot, Wageningen University
ClinicalTrials.gov Identifier: NCT00124852     History of Changes
Other Study ID Numbers: 2005_05/08, 6100.0004
Study First Received: July 26, 2005
Last Updated: January 11, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:
cognition
depression
elderly

Additional relevant MeSH terms:
Depression
Depressive Disorder
Cognition Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on July 29, 2014