The OPAL Study: Older People And n-3 Long-chain polyunsaturated fatty acids
Completed
- Conditions
- Cognitive and retinal functionEye Diseases
- Registration Number
- ISRCTN72331636
- Lead Sponsor
- Medical Research Council (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria
Healthy volunteers aged between 70-79 years of age, who have no previous history of diabetes or dementia. Participants will be selected from 20 GP practices.
Exclusion Criteria
1. Pre-existing type I or type II diabetes at baseline
2. Pre-existing dementia at baseline
3. Reported daily use of fish-oil supplements (in liquid or capsule form) at baseline
4. Mini-mental state examination (MMSE) score <24 at baseline screen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in cognitive function at 24 months determined by the California Verbal Learning Test<br>2. Change in rod sensitivity over 24 months of intervention as measured by electroretinogram
- Secondary Outcome Measures
Name Time Method 1. Cognitive performance as measured by immediate and delayed recall of a short story, tests of prospective memory, timed letter search/cancellation task, verbal fluency, digit span backwards, symbol digit modalities test, simple and choice reaction time, dual-task performance and spatial memory<br>2. Blood pressure<br>3. Measure of depression<br>4. Change in Body Mass Index<br>5. Compliance determined by counting the number of tablets remaining every 3 months, and by measuring the change in n-3 LCP concentration in buccal epithelial cells over 24 months<br>6. Number of hospital admissions for cardiovascular events over 24 months<br>7. Death<br>8. Colour vision measured by detecting sensitivity to colour contrast which is a good marker of central retinal function<br>9. Eye health assessed by carrying out a full ophthalmic examination