Condition category
Mental and Behavioural Disorders
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
14/02/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Ondine Rest, van de

ORCID ID

Contact details

Division of Human Nutrition
Wageningen University
Postbus 8129
Wageningen
6700 EV
Netherlands
+31 (0)317 485867
Ondine.vandeRest@wur.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2005_05/08

Study information

Scientific title

Acronym

MEMO

Study hypothesis

Counteract the process of mental deterioration in elderly people through enhancement of their EPA-DHA status

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

EPA-DHA

Primary outcome measures

Cognitive function and mental well-being

Secondary outcome measures

Quality of life

Overall trial start date

01/11/2005

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women
2. Aged 65 years and over
3. Informed consent signed

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

300

Participant 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

Recruitment start date

01/11/2005

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Division of Human Nutrition
Wageningen
6700 EV
Netherlands

Sponsor information

Organisation

Wageningen University (Nethelands)

Sponsor details

Division of Human Nutrition
Costerweg 50 / P.O.Box 9101
Wageningen
6700 HB
Netherlands
+31 (0)317 489111
info@wur.nl

Sponsor type

University/education

Website

http://www.wur.nl/UK/

Funders

Funder type

Research council

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes