Clinical trial NCT01185379: The Effects of Efalex Active 50+ on Cognitive Performance, Well-being and Cerebral Hemodynamics in Healthy Older Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Mood
Well-being
Cerebral Blood Flow
Keywords: Docosahexaenoic acid
omega 3
cerebral blood flow
Near Infrared spectroscopy
cognitive function
mood
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Efamol Ltd
First posted: 2010-08-19
Enrollment: 261
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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

Primary outcomes:
measure: Cognitive performance
timeFrame: 6 months
Secondary outcomes:
measure: Cerebral Hemodynamics
timeFrame: 6 months
measure: Mood/well-being
timeFrame: 6 months
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: David O Kennedy, PhD
role: PRINCIPAL_INVESTIGATOR
References: