MEMO study: Mental health in Elderly Maintained with Omega-3

ISRCTN	ISRCTN46249783
DOI	https://doi.org/10.1186/ISRCTN46249783
Secondary identifying numbers	2005_05/08

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Ms Ondine Rest, van de
Scientific

Division of Human Nutrition
Wageningen University
Postbus 8129
Wageningen
6700 EV
Netherlands

Phone	+31 (0)317 485867
Email	Ondine.vandeRest@wur.nl

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	MEMO
Study objectives	Counteract the process of mental deterioration in elderly people through enhancement of their EPA-DHA status
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Depressive disorders, Depression, Cognitive decline
Intervention	1. 400 mg EPA-DHA in capsules 2. 1.8 g EPA-DHA in capsules 3. Placebo oil capsules
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	EPA-DHA
Primary outcome measure	Cognitive function and mental well-being
Secondary outcome measures	Quality of life
Overall study start date	01/11/2005
Completion date	01/07/2007

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	300
Key inclusion criteria	1. Men and women 2. Aged 65 years and over 3. Informed consent signed
Key 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
Date of first enrolment	01/11/2005
Date of final enrolment	01/07/2007

Division of Human Nutrition

Wageningen
6700 EV
Netherlands

Wageningen University (Nethelands)
University/education

Division of Human Nutrition
Costerweg 50 / P.O.Box 9101
Wageningen
6700 HB
Netherlands

Research council

ZON-MW, The Netherlands Organization for Health Research and Development

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan