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Completed

NCT Number: NCT01185379

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

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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efalex active 50+

Dietary Supplement

4 x 500 mg Efalax Active 50+, to be taken daily for 6 months.

DHA rich fish oil

Dietary Supplement

4 x 500 mg DHA rich tuna oil to be taken daily for 6 months

Placebo

Dietary Supplement

4 x 500 mg capsules to be taken daily for 6 months

Primary outcomes

  1. Cognitive performance

    Time frame: 6 months

    Performance on a number of tasks assessing cognitive function across domains (attention, memory, executive function) will be measured.

Secondary outcomes

  1. Cerebral Hemodynamics

    Time frame: 6 months

    Cerebral blood flow response to cognitive tasks will be assessed using Near Infrared Spectroscopy (NIRS). General cerebral blood flow will be assessed using Transcranial Doppler (TCD)

  2. Mood/well-being

    Time frame: 6 months

    Mood and well-being will be assessed using a number of measures:

    Bond-Lader visual analogue scales, Profile of Mood States (POMS), General Health Questionnaire (GHQ), Pittsburgh Sleep Quality Index (PSQI)

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Efamol Ltd

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 19, 2010
Registry last updated
Sep 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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