The Effects of Efalex Active 50+ on Cognitive Performance, Well-being &

Status Completed

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.

Clinical Trial Description

n/a

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

Clinical Trial Details

NCT number	NCT01185379
Study type	Interventional
Source	Northumbria University
Contact
Status	Completed
Phase	N/A
Start date	July 2010
Completion date	June 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT03708692` - Menstrual Cycle Phases on Recovery and Cognitive Function
Active, not recruiting	`NCT04505345` - Virtual Reality Cognitive Training in Alcohol Use Disorder	N/A
Completed	`NCT04430465` - Effects of Wholegrains on Children's Health (KORN)	N/A
Completed	`NCT02915913` - Effects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults	N/A
Completed	`NCT01410097` - Physical and Cognitive Function - Look AHEAD Ancillary Study	N/A
Completed	`NCT03826121` - Efficacy and Safety of Sesame Oil Cake Extract on Improvement of Cognitive Function	N/A
Recruiting	`NCT05621278` - Children to Adults Mental and Psychosomatic Health Study (CAMPS)
Completed	`NCT05498415` - Feasibility, Acceptability, and Efficacy of the Sleep Move Stand Study	N/A
Completed	`NCT03208569` - Anticholinergic Burden - Treatment Optimization
Completed	`NCT03793777` - The Effect of Aronia Melanocarpa Extract on Cognitive Function	N/A
Recruiting	`NCT05525299` - Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors	N/A
Completed	`NCT03698123` - Performance Nutrition for Residents and Fellows	N/A
Completed	`NCT04543500` - Self-regulation of Prefrontal Cortex During Emotional Cognitive Control	N/A
Recruiting	`NCT05891977` - Effect of Tomato Paste Consumption on the Microbiota-gut-brain Axis in Healthy Adults	N/A
Recruiting	`NCT05591885` - Nutrilite Memory Builder on the Improvement of Cognitive Function	N/A
Active, not recruiting	`NCT05575752` - Acute Health Effects of High Temperature Exposure	N/A
Completed	`NCT03716609` - Effects of Magnesium Supplementation on Hemodynamic Parameters and Cognitive Function	N/A
Completed	`NCT02763514` - The Effects of DHA- and EPA-enriched Oils on Cognitive Function and Mood	N/A
Completed	`NCT02675621` - Investigation of Acute Mood and Cognitive Performance Effects of Beverages Containing Phenolics in Healthy Adults	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms