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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01185379

Enrollment

261

Registered

2010-08-19

Start date

2010-07-31

Completion date

2012-06-30

Last updated

2012-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Docosahexaenoic acid, omega 3, cerebral blood flow, Near Infrared spectroscopy, cognitive function, mood

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.

Interventions

DIETARY_SUPPLEMENTEfalex active 50+

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

DIETARY_SUPPLEMENTDHA rich fish oil

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

DIETARY_SUPPLEMENTPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Cerebral Hemodynamics	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)
Mood/well-being	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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026