Cognitive Impairment, Depression
Conditions
Keywords
cognition, depression, elderly
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.
Detailed description
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.
Interventions
BEHAVIORALn-3 Fatty Acid Supplementation
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men and women * Aged 65 years and over * Informed consent signed
Exclusion criteria
* A score of \> 16 on the CES-D (Centre for Epidemiological Studies-Depression Scale * A score of \< 21 points on MMSE (Mini-Mental State Examination) * Current or recent (\<4 weeks) use of fish oil supplements or intake of more than 4 times fish as judged by a fish consumption questionnaire * Current use of pharmacological antidepressants * Current use of dementia (Alzheimer) medication * Serious liver disease * Use of more than 4 glasses of alcohol per day * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function | — |
| Depression | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life | — |
Countries
Netherlands
Outcome results
None listed