Trial | NCT01185379  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    261
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.
Study Started
Jul 31
2010
Primary Completion
Jun 30
2012
Study Completion
Jun 30
2012
Last Update
Sep 26
2012
Estimate

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

Efalex Active 50+ Active Comparator

DHA-rich fish oil Active Comparator

Placebo Placebo Comparator

Criteria 

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
No Results Posted