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

Cognitive Function Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185379
• Other study ID #: 31N1
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: September 25, 2012
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: November 2010
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cerebral Blood Flow
• Cognitive Function
• Mood
• Well-being

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle upon Tyne	Tyne and Wear

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Efamol Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance	Performance on a number of tasks assessing cognitive function across domains (attention, memory, executive function) will be measured.	6 months	No
Secondary	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	No
Secondary	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	No