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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

May 22, 2013
June 14, 2013
May 27, 2015
May 2013
April 2015   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01877967 on ClinicalTrials.gov Archive Site
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)
Same as current
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
Same as current
 
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Alteration of Cognitive Function
  • Disturbance in Affect (Finding)
  • 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.
  • Dietary Supplement: placebo
  • 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.
    Intervention: Dietary Supplement: VSL#3
  • 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.
    Intervention: Dietary Supplement: placebo
Altman DG, Bland JM. Treatment allocation by minimisation. BMJ. 2005 Apr 9;330(7495):843. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
Same as current
July 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years to 75 Years   (Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Ireland
 
 
NCT01877967
8AA.N04022
Yes
Not Provided
Not Provided
Prof. Brian Lawlor, University of Dublin, Trinity College
University of Dublin, Trinity College
ACTIAL Farmaceutica Lda
Principal Investigator: Brian Lawlor Trinity College Dublin
University of Dublin, Trinity College
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP