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

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ClinicalTrials.gov Identifier: NCT01877967
Recruitment Status : Unknown
Verified May 2015 by Prof. Brian Lawlor, University of Dublin, Trinity College.
Recruitment status was:  Active, not recruiting
First Posted : June 14, 2013
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
ACTIAL Farmaceutica Lda
Information provided by (Responsible Party):
Prof. Brian Lawlor, University of Dublin, Trinity College

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.

Condition or disease Intervention/treatment Phase
Alteration of Cognitive Function Disturbance in Affect (Finding) Dietary Supplement: VSL#3 Dietary Supplement: placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : May 2013
Actual Primary Completion Date : April 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Changes in cognition [ Time Frame: Pre and Post the 12 week Intervention ]

    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)



Secondary Outcome Measures :
  1. Changes in Mood [ Time Frame: Pre and Post the 12 week Intervention ]

    Measures used to assess changes in mood:

    Centre for Epidemiologic Studies Depression Scale (CES-D) Hospital Anxiety and Depression Scale - Anxiety Scale (HADS-A)



Other Outcome Measures:
  1. Changes in levels of elements in blood [ Time Frame: Pre and Post the 12 week Intervention ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877967


Locations
Ireland
Institute of Neuroscience, Trinity College, Dublin
Dublin, Co. Dublin, Ireland, 0000
Sponsors and Collaborators
University of Dublin, Trinity College
ACTIAL Farmaceutica Lda
Investigators
Principal Investigator: Brian Lawlor Trinity College Dublin

Publications:
Responsible Party: Prof. Brian Lawlor, Professor, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT01877967     History of Changes
Other Study ID Numbers: 8AA.N04022
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015