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

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

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

Sponsors & Collaborators

• Efamol Ltd

  collaborator INDUSTRY

• Northumbria University

  lead OTHER

Principal Investigators

• David O Kennedy, PhD · Northumbria University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2012-06-30

Completion

2012-06-30

Countries

• United Kingdom

Study Locations