The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People
2 other identifiers
interventional
302
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2005
CompletedFirst Posted
Study publicly available on registry
July 28, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJanuary 12, 2011
January 1, 2011
1.2 years
July 26, 2005
January 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cognitive function
Depression
Secondary Outcomes (1)
Quality of life
Study Arms (3)
High Oleic Sunflower Oil
PLACEBO COMPARATOR400 mg EPA+DHA/day
ACTIVE COMPARATORlow dose fish oil
1800 mg EPA+DHA/day
ACTIVE COMPARATORhigh dose fish oil
Interventions
Eligibility Criteria
You may qualify if:
- Men and women
- Aged 65 years and over
- Informed consent signed
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wageningen University
Wageningen, Gelderland, 6700 EV, Netherlands
Related Publications (2)
Bouwens M, van de Rest O, Dellschaft N, Bromhaar MG, de Groot LC, Geleijnse JM, Muller 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.
PMID: 19515734DERIVEDvan 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. doi: 10.1093/ajcn/88.3.706.
PMID: 18779287DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisette de Groot, Dr Ir
Project leader
- STUDY DIRECTOR
Marianne Geleijnse, Dr
Project leader
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 26, 2005
First Posted
July 28, 2005
Study Start
October 1, 2005
Primary Completion
December 1, 2006
Study Completion
July 1, 2007
Last Updated
January 12, 2011
Record last verified: 2011-01