NCT01185379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 26, 2012

Status Verified

November 1, 2010

Enrollment Period

1.9 years

First QC Date

August 18, 2010

Last Update Submit

September 25, 2012

Conditions

Cognitive FunctionMoodWell-beingCerebral Blood Flow

Keywords

Docosahexaenoic acidomega 3cerebral blood flowNear Infrared spectroscopycognitive functionmood

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance

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

    6 months

Secondary Outcomes (2)

  • Cerebral Hemodynamics

    6 months

  • Mood/well-being

    6 months

Study Arms (3)

Efalex Active 50+

ACTIVE COMPARATOR
Dietary Supplement: Efalex active 50+

DHA-rich fish oil

ACTIVE COMPARATOR
Dietary Supplement: DHA rich fish oil

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Efalex active 50+DIETARY_SUPPLEMENT

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

Efalex Active 50+
DHA rich fish oilDIETARY_SUPPLEMENT

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

DHA-rich fish oil
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

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

Location

Study Officials

  • David O Kennedy, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. David Kennedy

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 19, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 26, 2012

Record last verified: 2010-11

Locations

GB(1)