Probiotic on Psychological and Cognitive Effects

Study Overview
=================
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.

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

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic - Lactobacillus Rhamnosus GG
* Other: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Participants in this arm will receive probiotic supplementation for 12 weeks (Lactobacillus Rhamnosus GG) | Dietary Supplement: Probiotic - Lactobacillus Rhamnosus GG<br>* 2 capsules per day for 90 days<br>|
| Placebo Comparator: Control<br>Participants in this arm will receive placebo that look similar to probiotics | Other: Placebo<br>* 2 placebo capsules per day for 90 days<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Probiotic, Cognitive Function, Mood