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

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01877967
• Other study ID #: 8AA.N04022
• Status: Active, not recruiting
• Phase: N/A
• First received: May 22, 2013
• Last updated: May 26, 2015
• Start date: May 2013
• Est. completion date: July 2015

Study information

• Verified date: May 2015
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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.
• placebo

Locations

Country	Name	City	State
Ireland	Institute of Neuroscience, Trinity College, Dublin	Dublin	Co. Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	ACTIAL Farmaceutica Lda

Country where clinical trial is conducted

Ireland, 

References & Publications (1)

Altman DG, Bland JM. Treatment allocation by minimisation. BMJ. 2005 Apr 9;330(7495):843. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in levels of elements in blood	Blood samples will be taken by a Research Assistant trained in Phlebotomy and tested for the presence of homocysteine, folate and vitamin B12 levels, PCR, glucose, insulin, ceramide and metabolomics	Pre and Post the 12 week Intervention	No
Primary	Changes in cognition	Measures used to assess cognition: Mini Mental State Exam National Adult Reading Test Free and Cued Selective Reminding Test (FCSRT) Category Fluency Task (Animal Fluency) Colour Trials test 1 & 2 Sustained Attention Response Task Choice Reaction Time Task Prospective Memory Task Self-Rated Memory Electrophysiological Measures (EEG spectral power - alpha range 8-14Hz)	Pre and Post the 12 week Intervention	No
Secondary	Changes in Mood	Measures used to assess changes in mood: Centre for Epidemiologic Studies Depression Scale (CES-D) Hospital Anxiety and Depression Scale - Anxiety Scale (HADS-A)	Pre and Post the 12 week Intervention	No