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 decline Depression	Behavior: Cognitive function  Behavior: Depression

Further Study Details: 

Primary Outcomes: Cognitive function; Depression
Secondary Outcomes: Quality of life
Expected Total Enrollment:  300

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.

Ages Eligible for Study:  65 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria: • Men and women • Aged 65 years and over • Informed consent signed

Exclusion Criteria: • A score of < 5 on the CES-D (Centre for Epidemiological Studies Depression Scale • A score of < 15 points on MMSE (Mini-Mental State Examination) • Current or recent (<4 weeks) use of fish oil supplements or intake of more than 8 g of n-3 fatty acids from fish per month (267 mg/day) as judged by a fish consumption questionnaire • Current use of pharmacological antidepressants • Current use of tranquillizers • Current use of dementia (Alzheimer) medication • Current use of anti-thrombotic medication • Serious liver disease • 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00124852

Ondine van de Rest      +31317485867    Ondine.vandeRest@wur.nl

Netherlands, Gelderland
      Wageningen University, Wageningen,  Gelderland,  6700 EV,  Netherlands

Study chairs or principal investigators

Lisette de Groot, Dr Ir,  Study Director,  Project leader   
Marianne Geleijnse, Dr,  Study Director,  Project leader   

Study ID Numbers:  2005_05/08; 6100.0004
Last Updated:  August 1, 2005
Record first received:  July 27, 2005
ClinicalTrials.gov Identifier:  NCT00124852
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-08-02