| - candidate number | 1159 |
| - NTR Number | NTR97 |
| - ISRCTN | ISRCTN46249783 |
| - Date ISRCTN created | 12-sep-2005 |
| - date ISRCTN requested | 18-aug-2005 |
| - Date Registered NTR | 28-jul-2005 |
| - Secondary IDs | 2005_05/08 |
| - Public Title | MEMO study: Mental health in Elderly Maintained with Omega-3. |
| - Scientific Title | Cognitive decline and early signs of depression in elderly people: the efficacy of n-3 fatty acid supplementation. |
| - ACRONYM | MEMO |
| - hypothesis | Counteract the process of mental deterioration in elderly people through enhancement of their EPA-DHA status. |
| - Healt Condition(s) or Problem(s) studied | Depressive disorders, Depression, Cognitive decline |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-nov-2005 |
| - planned closingdate | 1-jul-2007 |
| - Target number of participants | 300 |
| - Interventions | 1. 400 mg EPA-DHA in capsules; 2. 1.8 g EPA-DHA in capsules; 3. Placebo oil in capsules. |
| - Primary outcome | Cognitive function and mental well-being. |
| - Secondary outcome | Quality of life. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Ir. Ondine Rest, van de |
| - CONTACT for SCIENTIFIC QUERIES | PhD. Lisette Groot, de |
| - Sponsor/Initiator | Wageningen University, Division of Human Nutrition |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - 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. 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. |
| - Main changes (audit trail) | |
| - RECORD | 29-jul-2005 - 1-dec-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl