Probiotic on Psychological and Cognitive Effects
Evaluation of a Probiotic on Psychological and Cognitive Effects in Middle and Older Adults
1 other identifier
interventional
200
1 country
1
Brief Summary
This study will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG improves psychological status in middle age and older adults through a 12-week, randomized, double-blind, placebo-controlled clinical trial. Secondary analyses will be conducted to examine the possible benefits of probiotic supplementation on cognitive function and markers of physical health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 5, 2017
CompletedFirst Posted
Study publicly available on registry
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedFebruary 20, 2020
February 1, 2020
1.9 years
March 5, 2017
February 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R)
Depressive symptoms
Baseline and 12 week follow up
Change in score on State-Trait Anxiety Inventory
Anxiety symptoms
Baseline and 12 week follow up
Change in score on Perceived Stress Scale
Subjective stress
Baseline and 12 week follow up
Change in score on Positive and Negative Affect Schedule
Fluctuations in affect
Baseline and 12 week follow up
Change in score on Profile of Mood States
Fluctuations in affect - acute
Baseline and 12 week follow up
Change in score on Warwick-Edinburgh Mental Well-Being Scale
Subjective wellbeing
Baseline and 12 week follow up
Change in score on OECD Life Satisfaction scale (short)
Subjective wellbeing - general
Baseline and 12 week follow up
Change in score on Response to Stressful Events Scale
Emotion regulation
Baseline and 12 week follow up
Change in score on Connor-Davidson Resilience Scale
Emotional resilience
Baseline and 12 week follow up
Secondary Outcomes (12)
Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores
Baseline and 12 week follow up
Change in Dimension Card Sort Test, Flanker Inhibitory Control, and List Sorting Working Memory Test scores
Baseline and 12 week follow up
Change in Pattern Comparison Processing Speed Test scores
Baseline and 12 week follow up
Change in SF-36 scores
Baseline and 12 week follow up
Change in Pittsburgh Sleep Quality Index scores
Baseline and 12 week follow up
- +7 more secondary outcomes
Study Arms (2)
Probiotic
EXPERIMENTALParticipants in this arm will receive probiotic supplementation for 12 weeks (Lactobacillus Rhamnosus GG)
Control
PLACEBO COMPARATORParticipants in this arm will receive placebo that look similar to probiotics
Interventions
Eligibility Criteria
You may qualify if:
- Age 55-75 years
- Able to speak and read English
You may not qualify if:
- History of neurological, developmental, or severe psychiatric disorder (e.g. dementia, stroke, schizophrenia);
- Antibiotic use in the past 30 days;
- History of significant stomach or GI surgery (e.g. gastric bypass, cholecystectomy);
- History of alcohol or illicit drug dependence;
- History of severe heart, kidney, or liver problems (e.g. heart failure, liver failure);
- Regular use of an acid-blocking medication in the past 30 days (i.e. proton pump inhibitor, H2 blocker);
- Likely immunosuppression (e.g. chemotherapy treatment);
- Regular use of other pre- or probiotic supplements in the past 30 days;
- Severe gastrointestinal conditions including celiac disease, Crohn's disease, or diverticulitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kent State Universitylead
- iHealthcollaborator
Study Sites (1)
Kent State Uniersity
Kent, Ohio, 44242, United States
Related Publications (2)
Aljumaah MR, Bhatia U, Roach J, Gunstad J, Azcarate Peril MA. The gut microbiome, mild cognitive impairment, and probiotics: A randomized clinical trial in middle-aged and older adults. Clin Nutr. 2022 Nov;41(11):2565-2576. doi: 10.1016/j.clnu.2022.09.012. Epub 2022 Sep 28.
PMID: 36228569DERIVEDSanborn V, Aljumaah M, Azcarate-Peril MA, Gunstad J. Examining the cognitive benefits of probiotic supplementation in physically active older adults: A randomized clinical trial. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):871-882. doi: 10.1139/apnm-2021-0557. Epub 2022 May 26.
PMID: 35617704DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
John Gunstad, Ph.D.
Kent State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 5, 2017
First Posted
March 15, 2017
Study Start
February 1, 2017
Primary Completion
January 1, 2019
Study Completion
July 1, 2019
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share