The Effects of Efalex Active 50+ on Cognitive Performance, Well-being and Cerebral Hemodynamics in Healthy Older Adults
NCT ID: NCT01185379
Last Updated: 2012-09-26
Study Results
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Basic Information
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COMPLETED
NA
261 participants
INTERVENTIONAL
2010-07-31
2012-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Efalex Active 50+
Efalex active 50+
4 x 500 mg Efalax Active 50+, to be taken daily for 6 months.
DHA-rich fish oil
DHA rich fish oil
4 x 500 mg DHA rich tuna oil to be taken daily for 6 months
Placebo
Placebo
4 x 500 mg capsules to be taken daily for 6 months
Interventions
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Efalex active 50+
4 x 500 mg Efalax Active 50+, to be taken daily for 6 months.
DHA rich fish oil
4 x 500 mg DHA rich tuna oil to be taken daily for 6 months
Placebo
4 x 500 mg capsules to be taken daily for 6 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
70 Years
ALL
Yes
Sponsors
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Efamol Ltd
INDUSTRY
Northumbria University
OTHER
Responsible Party
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David Kennedy
Prof. David Kennedy
Principal Investigators
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David O Kennedy, PhD
Role: PRINCIPAL_INVESTIGATOR
Northumbria University
Locations
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Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Countries
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Other Identifiers
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31N1
Identifier Type: -
Identifier Source: org_study_id
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