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.

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.

Study Overview

• Status: Unknown
• Conditions: Alteration of Cognitive Function; Disturbance in Affect (Finding)
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: VSL#3

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Co. Dublin
    • Dublin, Co. Dublin, Ireland, 0000
      • Institute of Neuroscience, Trinity College, Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; This group will intake the recommended daily amount of the food supplement VSL#3 (two sachets of the supplement in powder form) every day for twelve weeks. The two sachets will either be taken together or one in the morning and one in the evening.	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_COMPARATOR: Placebo; This group will intake two sachets (2x4.4g) of a placebo each day for 12 weeks. The placebo is in the same powdered form as the food supplement taken by the intervention group. The two sachets will either be taken together or one in the morning and one in the evening.	Dietary supplement: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: Actial Farmaceutica S.r.l.
• Investigators: Principal Investigator: Brian Lawlor, University of Dublin, Trinity College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ANTICIPATED): July 1, 2015

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: June 13, 2013
• First Posted (ESTIMATE): June 14, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 8AA.N04022