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

University of Dublin, Trinity College

Status: Unknown

Conditions: Disturbance in Affect (Finding); Alteration of Cognitive Function

Treatments: Dietary Supplement: placebo; Dietary Supplement: VSL#3

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01877967

8AA.N04022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 65 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: VSL#3

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: placebo