NCT01877967

Investigating the Effect of Dietary Supplement VSL#3 on Cognition and Mood in Healthy Older Adults

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Dublin, Trinity College · Academic / Other
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Alteration of Cognitive Function
• Disturbance in Affect (Finding)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	VSL#3	The intervention group will be asked to ingest two sachets (2x4.4g) of the food supplement (VSL#3) each day for 12 weeks, either both at the same time, or one in the morning and one in the evening. This food supplement is in powder form and can be ingested with either cold food or any non-carbonated cold drink. The control group will be given a placebo, although as it is a double-blind intervention, will not know it is a placebo. They will similarly to the intervention group be asked to take two sachets (2x4.4g) of a powder rach day for 12 weeks, either both at the same time, or one in the morning and one in the evening.
DIETARY_SUPPLEMENT	placebo

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-04-01
• Completion: 2015-07-01
• First posted: 2013-06-14
• Last updated: 2015-05-27

Locations

1 site across 1 country: Ireland