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

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 Overview

• Status: Completed
• Conditions: Cerebral Blood Flow; Well-being; Cognitive Function; Mood
• Intervention / Treatment: Dietary supplement: Efalex active 50+; Dietary supplement: DHA rich fish oil; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 261
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne and Wear
    • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
      • Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; 4 x 500 mg capsules to be taken daily for 6 months
Active Comparator: Efalex Active 50+	Dietary supplement: Efalex active 50+; 4 x 500 mg Efalax Active 50+, to be taken daily for 6 months.
Active Comparator: DHA-rich fish oil	Dietary supplement: DHA rich fish oil; 4 x 500 mg DHA rich tuna oil to be taken daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance	Performance on a number of tasks assessing cognitive function across domains (attention, memory, executive function) will be measured.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral Hemodynamics	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)	6 months
Mood/well-being	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)	6 months

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: Efamol Ltd
• Investigators: Principal Investigator: David O Kennedy, PhD, Northumbria University

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: August 18, 2010
• First Posted (Estimate): August 19, 2010

Study Record Updates

• Last Update Posted (Estimate): September 26, 2012
• Last Update Submitted That Met QC Criteria: September 25, 2012
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: cognitive function; omega 3; Docosahexaenoic acid; cerebral blood flow; Near Infrared spectroscopy; mood
• Other Study ID Numbers: 31N1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No