No registrations found.
ID
Source
Brief title
Health condition
Cognitive decline
Depression
Sponsors and support
Ir. O. van de Rest
Dr. Ir. L.C.P.G.M. de Groot
Dr. J.M. Geleijnse
Prof. Dr. Ir. F.J. Kok
Prof. W.A. van Staveren
University Medical Centre / Radboud University Nijmegen (Geriatrics):
Prof. Dr. W.H.L. Hoefnagels
Free University Amsterdam (Psychiatrics):
Prof. Dr. A.T.F. Beekman
Intervention
Outcome measures
Primary outcome
Cognitive function and mental well-being.
Secondary outcome
Quality of life.
Background 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. 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 objective
Counteract the process of mental deterioration in elderly people through enhancement of their EPA-DHA status.
Study design
N/A
Intervention
1. 400 mg EPA-DHA in capsules;
2. 1.8 g EPA-DHA in capsules;
3. Placebo oil in capsules.
P.O. Box 8129
Ondine Rest, van de
Wageningen 6700 EV
The Netherlands
+31 (0)317 485867
Ondine.vandeRest@wur.nl
P.O. Box 8129
Ondine Rest, van de
Wageningen 6700 EV
The Netherlands
+31 (0)317 485867
Ondine.vandeRest@wur.nl
Inclusion criteria
1. Men and women;
2. Aged 65 years and over;
3. Informed consent signed.
Exclusion criteria
1. A score of > 16 on the CES-D (Centre for Epidemiological Studies-Depression Scale;
2. A score of < 21 points on MMSE (Mini-Mental State Examination);
3. Current or recent (<4 weeks) use of fish oil supplements or intake of more than 4 times fish/ week; 24.35 g of EPA-DHA from fish per month (800 mg/day) as judged by a fish consumption questionnaire;
4. Current use of pharmacological antidepressants;
5. Current use of dementia (Alzheimer) medication;
6. Serious liver disease;
7. Use of more than 4 glasses of alcohol per day;
8. Unable to participate as judged by the responsible medical physician;
9. Allergy to fish(oil);
10. Swallowing problems;
11. Participation in another clinical trial less than 2 months before the start of the trial or at the same time.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL65 |
| NTR-old | NTR97 |
| Other | METC-WU : 2005_05/08 |
| ISRCTN | ISRCTN46249783 |