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The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People
This study has been completed.
Sponsor:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00124852
First received: July 26, 2005
Last updated: January 11, 2011
Last verified: January 2011
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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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00124852
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
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 |
Keywords provided by Wageningen University:
|
cognition depression elderly |
Additional relevant MeSH terms:
|
Depression Cognition Disorders Behavioral Symptoms Neurocognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on August 18, 2017