Clinical trial NCT01877967: Investigating the Effect of Dietary Supplement VSL#3 on Cognition and Mood in Healthy Older Adults
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alteration of Cognitive Function
Disturbance in Affect (Finding)
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Actial Farmaceutica S.r.l.
First posted: 2013-06-14
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Aged between 65 and 75
* MMSE score \> 23
* Willingness to give informed consent
* Commitment to take the VSL#3 supplement daily for 12 weeks
* Alcohol consumption less than 21 units per week (men), 14 units per week (women)

Exclusion Criteria:

* Current psychoactive medication
* Significant active medical conditions
* History of major psychiatric or neurological condition
* Smoker
* History of epilepsy
* History of traumatic brain injury
* History of immunodeficiency
* Taking immunosuppressants or corticosteroids

Primary outcomes:
measure: Changes in cognition
timeFrame: Pre and Post the 12 week Intervention
Secondary outcomes:
measure: Changes in Mood
timeFrame: Pre and Post the 12 week Intervention
Other outcomes:
measure: Changes in levels of elements in blood
timeFrame: Pre and Post the 12 week Intervention
Locations:
city: Dublin
country: Ireland
facility: Institute of Neuroscience, Trinity College, Dublin
state: Co. Dublin
Study officials:
affiliation: University of Dublin, Trinity College
name: Brian Lawlor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Altman DG, Bland JM. Treatment allocation by minimisation. BMJ. 2005 Apr 9;330(7495):843. doi: 10.1136/bmj.330.7495.843. No abstract available.