Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00124852
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : January 12, 2011
Sponsor:
Information provided by:
Wageningen University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Depression Behavioral: n-3 Fatty Acid Supplementation Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
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
Study Start Date : October 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cognitive function
  2. Depression

Secondary Outcome Measures :
  1. Quality of life

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV
Sponsors and Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Layout table for investigator information
Study Director: Lisette de Groot, Dr Ir Project leader
Study Director: Marianne Geleijnse, Dr Project leader
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Prof Dr Lisette CPGM de Groot, Wageningen University
ClinicalTrials.gov Identifier: NCT00124852    
Other Study ID Numbers: 2005_05/08
6100.0004
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: January 2011
Keywords provided by Wageningen University:
cognition
depression
elderly
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms