NCT01185379

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Northumbria University · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cognitive Function
• Mood
• Well-being
• Cerebral Blood Flow

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Efalex active 50+	4 x 500 mg Efalax Active 50+, to be taken daily for 6 months.
DIETARY_SUPPLEMENT	DHA rich fish oil	4 x 500 mg DHA rich tuna oil to be taken daily for 6 months
DIETARY_SUPPLEMENT	Placebo	4 x 500 mg capsules to be taken daily for 6 months

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-08-19
• Last updated: 2012-09-26

Locations

1 site across 1 country: United Kingdom