Probiotic on Psychological and Cognitive Effects

Not Applicable

Completed

• Conditions: Aging
• Interventions: Dietary Supplement: Probiotic - Lactobacillus Rhamnosus GG; Other: Placebo

• Registration Number: NCT03080818
• Lead Sponsor: Kent State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-03-05
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Primary Completion: 2019-01-01
• Study Completion: 2019-07-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic - Lactobacillus Rhamnosus GG	Participants in this arm will receive probiotic supplementation for 12 weeks (Lactobacillus Rhamnosus GG)
Control	Placebo	Participants in this arm will receive placebo that look similar to probiotics

Primary Outcome Measures

Name	Time	Method
Change in score on Response to Stressful Events Scale	Baseline and 12 week follow up	Emotion regulation
Change in score on OECD Life Satisfaction scale (short)	Baseline and 12 week follow up	Subjective wellbeing - general
Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R)	Baseline and 12 week follow up	Depressive symptoms
Change in score on Positive and Negative Affect Schedule	Baseline and 12 week follow up	Fluctuations in affect
Change in score on Connor-Davidson Resilience Scale	Baseline and 12 week follow up	Emotional resilience
Change in score on State-Trait Anxiety Inventory	Baseline and 12 week follow up	Anxiety symptoms
Change in score on Perceived Stress Scale	Baseline and 12 week follow up	Subjective stress
Change in score on Profile of Mood States	Baseline and 12 week follow up	Fluctuations in affect - acute
Change in score on Warwick-Edinburgh Mental Well-Being Scale	Baseline and 12 week follow up	Subjective wellbeing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kent State Uniersity; 🇺🇸 Kent, Ohio, United States