Probiotic on Psychological and Cognitive Effects

Evaluation of a Probiotic on Psychological and Cognitive Effects in Middle and Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: Probiotic - Lactobacillus Rhamnosus GG; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Kent, Ohio, United States, 44242
      • Kent State Uniersity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Probiotic; Participants in this arm will receive probiotic supplementation for 12 weeks (Lactobacillus Rhamnosus GG)	Dietary supplement: Probiotic - Lactobacillus Rhamnosus GG; 2 capsules per day for 90 days
PLACEBO_COMPARATOR: Control; Participants in this arm will receive placebo that look similar to probiotics	Other: Placebo; 2 placebo capsules per day for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores	Memory	Baseline and 12 week follow up
Change in Dimension Card Sort Test, Flanker Inhibitory Control, and List Sorting Working Memory Test scores	Executive function/Attention	Baseline and 12 week follow up
Change in Pattern Comparison Processing Speed Test scores	Processing Speed	Baseline and 12 week follow up
Change in SF-36 scores	Quality of Life	Baseline and 12 week follow up
Change in Pittsburgh Sleep Quality Index scores	Sleep patterns	Baseline and 12 week follow up
Change in Gastrointestinal Symptom Rating Scale scores	Subjective gastrointestinal symptoms	Baseline and 12 week follow up
Change in HbA1c and fasting glucose values	Laboratory measures of glycemic control	Baseline and 12 week follow up
Change in C-reactive protein, Interleukin-6, and TNF-alpha values	Laboratory measures of inflammation	Baseline and 12 week follow up
Change in Total Cholesterol, HDL, LDL, and VLDL values	Laboratory meausres of lipid levels	Baseline and 12 week follow up
Change in waking cortisol levels	Laboratory measure of cortisol	Baseline and 12 week follow up
Change in composition of the gut microbiome	Laboratory measure of gut microbiome	Baseline and 12 week follow up
Change in oral microbiome composition	Laboratory measure of oral microbiome	Baseline and 12 week follow up

Collaborators and Investigators

• Sponsor: Kent State University
• Collaborators: iHealth
• Investigators: Principal Investigator: John Gunstad, Ph.D., Kent State University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): July 1, 2019

Study Registration Dates

• First Submitted: March 5, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (ACTUAL): March 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Probiotic, Cognitive Function, Mood
• Other Study ID Numbers: Kent State University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No