Clinical trial NCT00124852: The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People
Official title: The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People: a Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Depression
Keywords: cognition
depression
elderly
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2005-07-28
Enrollment: 302
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Cognitive function
measure: Depression
Secondary outcomes:
measure: Quality of life
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
state: Gelderland
Study officials:
affiliation: Project leader
name: Lisette de Groot, Dr Ir
role: STUDY_DIRECTOR
affiliation: Project leader
name: Marianne Geleijnse, Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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. doi: 10.1093/ajcn/88.3.706.