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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00124852

First Posted: July 28, 2005

Last Update Posted: January 12, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Wageningen University

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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:

MedlinePlus related topics: Mental Health

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bouwens M, van de Rest O, Dellschaft N, Bromhaar MG, de Groot LC, Geleijnse JM, Müller M, Afman LA. Fish-oil supplementation induces antiinflammatory gene expression profiles in human blood mononuclear cells. Am J Clin Nutr. 2009 Aug;90(2):415-24. doi: 10.3945/ajcn.2009.27680. Epub 2009 Jun 10.

van de Rest O, Geleijnse JM, Kok FJ, van Staveren WA, Hoefnagels WH, Beekman AT, de Groot LC. Effect of fish-oil supplementation on mental well-being in older subjects: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2008 Sep;88(3):706-13.


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
First Submitted:	July 26, 2005
First Posted:	July 28, 2005
Last Update Posted:	January 12, 2011
Last Verified:	January 2011

Keywords provided by Wageningen University:


cognition depression elderly

Additional relevant MeSH terms:


Depression Cognitive Dysfunction Behavioral Symptoms	Cognition Disorders Neurocognitive Disorders Mental Disorders

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