Probiotic on Psychological and Cognitive Effects

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080818
• Other study ID #: Kent State University
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: February 2020
• Source: Kent State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Probiotic - Lactobacillus Rhamnosus GG
2 capsules per day for 90 days

Other:
• Placebo
2 placebo capsules per day for 90 days

Locations

Country	Name	City	State
United States	Kent State Uniersity	Kent	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kent State University	iHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R)	Depressive symptoms	Baseline and 12 week follow up
Primary	Change in score on State-Trait Anxiety Inventory	Anxiety symptoms	Baseline and 12 week follow up
Primary	Change in score on Perceived Stress Scale	Subjective stress	Baseline and 12 week follow up
Primary	Change in score on Positive and Negative Affect Schedule	Fluctuations in affect	Baseline and 12 week follow up
Primary	Change in score on Profile of Mood States	Fluctuations in affect - acute	Baseline and 12 week follow up
Primary	Change in score on Warwick-Edinburgh Mental Well-Being Scale	Subjective wellbeing	Baseline and 12 week follow up
Primary	Change in score on OECD Life Satisfaction scale (short)	Subjective wellbeing - general	Baseline and 12 week follow up
Primary	Change in score on Response to Stressful Events Scale	Emotion regulation	Baseline and 12 week follow up
Primary	Change in score on Connor-Davidson Resilience Scale	Emotional resilience	Baseline and 12 week follow up
Secondary	Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores	Memory	Baseline and 12 week follow up
Secondary	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
Secondary	Change in Pattern Comparison Processing Speed Test scores	Processing Speed	Baseline and 12 week follow up
Secondary	Change in SF-36 scores	Quality of Life	Baseline and 12 week follow up
Secondary	Change in Pittsburgh Sleep Quality Index scores	Sleep patterns	Baseline and 12 week follow up
Secondary	Change in Gastrointestinal Symptom Rating Scale scores	Subjective gastrointestinal symptoms	Baseline and 12 week follow up
Secondary	Change in HbA1c and fasting glucose values	Laboratory measures of glycemic control	Baseline and 12 week follow up
Secondary	Change in C-reactive protein, Interleukin-6, and TNF-alpha values	Laboratory measures of inflammation	Baseline and 12 week follow up
Secondary	Change in Total Cholesterol, HDL, LDL, and VLDL values	Laboratory meausres of lipid levels	Baseline and 12 week follow up
Secondary	Change in waking cortisol levels	Laboratory measure of cortisol	Baseline and 12 week follow up
Secondary	Change in composition of the gut microbiome	Laboratory measure of gut microbiome	Baseline and 12 week follow up
Secondary	Change in oral microbiome composition	Laboratory measure of oral microbiome	Baseline and 12 week follow up