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

NCT01877967 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-05-27

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Actial Farmaceutica S.r.l.

    collaborator INDUSTRY
  • University of Dublin, Trinity College

    lead OTHER

Principal Investigators

  • Brian Lawlor · University of Dublin, Trinity College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-04-30
Completion
2015-07-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01877967 on ClinicalTrials.gov