Clinical trial NCT03080818: Probiotic on Psychological and Cognitive Effects
Official title: Evaluation of a Probiotic on Psychological and Cognitive Effects in Middle and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Probiotic, Cognitive Function, Mood
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: iHealth
First posted: 2017-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* Age 55-75 years
* Able to speak and read English

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R)
timeFrame: Baseline and 12 week follow up
measure: Change in score on State-Trait Anxiety Inventory
timeFrame: Baseline and 12 week follow up
measure: Change in score on Perceived Stress Scale
timeFrame: Baseline and 12 week follow up
measure: Change in score on Positive and Negative Affect Schedule
timeFrame: Baseline and 12 week follow up
measure: Change in score on Profile of Mood States
timeFrame: Baseline and 12 week follow up
measure: Change in score on Warwick-Edinburgh Mental Well-Being Scale
timeFrame: Baseline and 12 week follow up
measure: Change in score on OECD Life Satisfaction scale (short)
timeFrame: Baseline and 12 week follow up
measure: Change in score on Response to Stressful Events Scale
timeFrame: Baseline and 12 week follow up
measure: Change in score on Connor-Davidson Resilience Scale
timeFrame: Baseline and 12 week follow up
Secondary outcomes:
measure: Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores
timeFrame: Baseline and 12 week follow up
measure: Change in Dimension Card Sort Test, Flanker Inhibitory Control, and List Sorting Working Memory Test scores
timeFrame: Baseline and 12 week follow up
measure: Change in Pattern Comparison Processing Speed Test scores
timeFrame: Baseline and 12 week follow up
measure: Change in SF-36 scores
timeFrame: Baseline and 12 week follow up
measure: Change in Pittsburgh Sleep Quality Index scores
timeFrame: Baseline and 12 week follow up
measure: Change in Gastrointestinal Symptom Rating Scale scores
timeFrame: Baseline and 12 week follow up
measure: Change in HbA1c and fasting glucose values
timeFrame: Baseline and 12 week follow up
measure: Change in C-reactive protein, Interleukin-6, and TNF-alpha values
timeFrame: Baseline and 12 week follow up
measure: Change in Total Cholesterol, HDL, LDL, and VLDL values
timeFrame: Baseline and 12 week follow up
measure: Change in waking cortisol levels
timeFrame: Baseline and 12 week follow up
measure: Change in composition of the gut microbiome
timeFrame: Baseline and 12 week follow up
measure: Change in oral microbiome composition
timeFrame: Baseline and 12 week follow up
Other outcomes:
Locations:
city: Kent
country: United States
facility: Kent State Uniersity
state: Ohio
Study officials:
affiliation: Kent State University
name: John Gunstad, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sanborn 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.