The Effects of Efalex Active 50+ on Cognitive Performance, Well-being and Cerebral Hemodynamics in Healthy Older Adults

Study Overview
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Brief Summary
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Dietary intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs) is inversely associated with cognitive decline and dementia (e.g. Kalmijn et al. 2004, Heude et al. 2003, Morris et al. 2005, Dullemeijer et al. 2009). Recently, the effects of supplemental docosahexaenoic acid (DHA) on behavioural outcomes in older adults has been explored, however two trials addressing this issue have published conflicting results regarding the efficacy of DHA supplementation, with one reporting a benefit of treatment on cognitive performance (Yurko-Mauro et al. 2010), while the other did not (Dangour et al. 2010). One area of research that has yet to be explored in this cohort is the effects of n-3 PUFAs on brain function in physiological terms. It is also possible that n-3 PUFAs, in combination with other compounds, may be more beneficial than treatment with n-3 PUFAs in isolation. The current study will explore several separate hypotheses within the same cohort. These are that Efalex Active 50+ may have a beneficial effect on: Cognitive performance Mental fatigue in response to cognitively demanding tasks Self-reported mood/well-being Task-related cerebral blood flow response The proposed study therefore has two aims; the primary aim is to evaluate the cognitive and mood/well-being effects of Efalex Active 50+, a dietary supplement containing a number of potentially cognition enhancing components including DHA, phosphatidylserine, vitamin B12, folic acid and Ginkgo biloba, compared with placebo in a sample of older adults aged 50-70 years (Cognitive Study). The second is to evaluate the cerebral haemodynamic effects of the same treatment formulation in a sample drawn from the same population, with the addition of a third DHA-only arm (Hemodynamics Study). The intervention period will be 6 months.

Official Title
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Investigation of the Effects of Efalex Active 50+ on Cognitive Performance, Well-being and Cerebral Hemodynamics in Healthy Adults Aged 50-70 Years Reporting Subjective Memory Deficits

Conditions
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Cognitive Function, Mood, Well-being, Cerebral Blood Flow

Intervention / Treatment
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* Dietary Supplement: Efalex active 50+
* Dietary Supplement: DHA rich fish oil
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy Aged 50-70 years Low consumer of oily fish (≤ 1 portion/month) Has not taken vitamin/herbal supplements in the past 3 months Has not taken omega-3 supplement (including cod liver oil) in the past 2 years Has a good level of written and spoken English Has an MMSE score > 24 Is suffering from a memory complaint (MAC-Q score > 24) Exclusion Criteria: BMI > 35 Smokes more than 15 cigarettes per day History of alcohol/drug abuse Currently taking statins/antidepressant/blood thinning medication Has high blood pressure Suffers from migraines/anaemia/heart or lung disorder/diabetes/active infections/jaundice/haemophilia or other clotting disease Has learning difficulties/dyslexia/colour blindness Is HIV positive Has hepatitis

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Efalex Active 50+<br> | Dietary Supplement: Efalex active 50+<br>* 4 x 500 mg Efalax Active 50+, to be taken daily for 6 months.<br>|
| Active Comparator: DHA-rich fish oil<br> | Dietary Supplement: DHA rich fish oil<br>* 4 x 500 mg DHA rich tuna oil to be taken daily for 6 months<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 4 x 500 mg capsules to be taken daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance | Performance on a number of tasks assessing cognitive function across domains (attention, memory, executive function) will be measured. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Hemodynamics | Cerebral blood flow response to cognitive tasks will be assessed using Near Infrared Spectroscopy (NIRS). General cerebral blood flow will be assessed using Transcranial Doppler (TCD) | 6 months | 
| Mood/well-being | Mood and well-being will be assessed using a number of measures: Bond-Lader visual analogue scales, Profile of Mood States (POMS), General Health Questionnaire (GHQ), Pittsburgh Sleep Quality Index (PSQI) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Docosahexaenoic acid, omega 3, cerebral blood flow, Near Infrared spectroscopy, cognitive function, mood