Age-Related Cognitive Decline, Age-Related Memory Disorders
Conditions
Keywords
Cognition, Memory, Nutrition, Omega-3, DHA
Brief summary
The purpose of this study is to investigate the effect of docosahexaenoic acid (DHA, 22:6n-3) in improving cognitive functions in subjects with age-related cognitive decline. DHA is a long chain omega-3 fatty acid (LC-PUFA) that plays an important role in neural and visual development and cardiovascular health.
Interventions
DIETARY_SUPPLEMENTDHA (nutritional supplement) or placebo
oral 900mg/day
Sponsors
DSM Nutritional Products, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females, aged 55 or greater. * Have a subjective memory complaint and have a Logical Memory subtest (of the Wechsler Memory Scale - III \[WMS-III\]) raw score one standard deviation or greater below the mean of a younger population. * Have the ability to understand the requirements of the study; be willing to provide written informed consent; and agree to abide by the study restrictions and return for the required assessments. * If taking non-prohibited medication, be on a stable drug regimen (in prior 3 months).
Exclusion criteria
* Have a screening Mini-Mental State Examination (MMSE) \< 26. * Consume greater than 200 mg/day DHA as assessed on a DHA Food Frequency Questionnaire in the prior 2 months to screening. * Use nutritional fish oil, flaxseed oil, omega-3 supplements, or huperzine in the prior 2 months to screening. * Use acetylcholinesterase inhibitors or memantine in the prior 2 months to screening. * Use major anti-psychotics or major anti-depressants. * Use lipase inhibitors such as Xenical® (orlistat). * History of major medical conditions including ischemic stroke, head trauma with loss of consciousness, epilepsy, psychosis, vascular dementia, depression (Geriatric Depression \[15-item\] \> 5), myocardial infarction (within 1 year), uncontrolled diabetes, or blindness. * History of major surgery within the past 6 months. * Current use or history of drug and/or alcohol abuse within 5 years. * Administration of any investigational product within the past 30 days. * Inability to swallow capsules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the effects of DHA, a nutritional supplement (900 mg/d) on improving cognitive functions (i.e. working memory, memory retention, attention, and executive function) in healthy elderly subjects at 24 weeks | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Effects of DHA on visual acuity, levels of plasma phospholipids, and evaluating the safety and tolerability of the DHA dose administered | 24 weeks |
| The study will include a screening period, baseline, and 24 week treatment period. | — |
Countries
United States
Outcome results
None listed