Alteration of Cognitive Function Clinical Trial
Official title:
A Randomised Double-blind Placebo-controlled Trial Investigating the Effect of Dietary Supplement VSL#3 on Memory, Attention, Executive Function and Mood in Healthy Older Adults.
This research aims to determine whether a 12 week daily dose of VSL#3 has any measurable effects on memory, attention, executive function or self-reported mood and anxiety in healthy older adults.
This research aims to investigate the effect of dietary supplement VSL#3 on memory,
attention, executive function and mood in healthy older adults.
The study will be a randomised double-blind placebo-controlled design and eighty
participants will be recruited to take part. Forty participants will be randomly allocated
to the food supplement and 40 to placebo. As the sample is initially self-selecting where
individuals volunteer to take part, a minimisation procedure will be used to randomise group
allocation (Altman & Bland, 2005), with volunteers stratified by gender. Neither the
participant nor the research assistant supplying the supplement will know which preparation
is administered, thus ensuring double-blind administration.
Participants will be asked to take the food supplement daily for 12 weeks and the pre- and
post- intervention data will be collected immediately before and after this time period.
Both pre- and post-intervention data will be collected using validated neuropsychological
measures, cognitive measures, EEG and self-report questionnaires. Blood sampling will be
conducted pre- and post-intervention by a Research Assistant trained in phlebotomy. Analysis
will be carried out on each of the measures using a two-way ANCOVA, using the pre-treatment
score as covariate.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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