NCT01877967

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 14, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.9 years

First QC Date

May 22, 2013

Last Update Submit

May 26, 2015

Conditions

Alteration of Cognitive FunctionDisturbance in Affect (Finding)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in Mood

    Pre and Post the 12 week Intervention

Other Outcomes (1)

  • Changes in levels of elements in blood

    Pre and Post the 12 week Intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

VSL#3DIETARY_SUPPLEMENT

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.

Intervention
placeboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Neuroscience, Trinity College, Dublin

Dublin, Co. Dublin, 0000, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 15817555BACKGROUND

MeSH Terms

Conditions

Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

  • Brian Lawlor

    University of Dublin, Trinity College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2013

First Posted

June 14, 2013

Study Start

May 1, 2013

Primary Completion

April 1, 2015

Study Completion

July 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

IE(1)