Kent State Uniersity
Kent, Ohio, 44242, United States
Completed
NCT Number: NCT03080818
Probiotic on Psychological and Cognitive Effects
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.
Completed
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Notify MeKey information
Conditions
Age range
55 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Probiotic - Lactobacillus Rhamnosus GG
Dietary Supplement2 capsules per day for 90 days
Placebo
Other2 placebo capsules per day for 90 days
Primary outcomes
-
Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R)
Time frame: Baseline and 12 week follow up
Depressive symptoms
-
Change in score on State-Trait Anxiety Inventory
Time frame: Baseline and 12 week follow up
Anxiety symptoms
-
Change in score on Perceived Stress Scale
Time frame: Baseline and 12 week follow up
Subjective stress
-
Change in score on Positive and Negative Affect Schedule
Time frame: Baseline and 12 week follow up
Fluctuations in affect
-
Change in score on Profile of Mood States
Time frame: Baseline and 12 week follow up
Fluctuations in affect - acute
-
Change in score on Warwick-Edinburgh Mental Well-Being Scale
Time frame: Baseline and 12 week follow up
Subjective wellbeing
-
Change in score on OECD Life Satisfaction scale (short)
Time frame: Baseline and 12 week follow up
Subjective wellbeing - general
-
Change in score on Response to Stressful Events Scale
Time frame: Baseline and 12 week follow up
Emotion regulation
-
Change in score on Connor-Davidson Resilience Scale
Time frame: Baseline and 12 week follow up
Emotional resilience
Secondary outcomes
-
Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores
Time frame: Baseline and 12 week follow up
Memory
-
Change in Dimension Card Sort Test, Flanker Inhibitory Control, and List Sorting Working Memory Test scores
Time frame: Baseline and 12 week follow up
Executive function/Attention
-
Change in Pattern Comparison Processing Speed Test scores
Time frame: Baseline and 12 week follow up
Processing Speed
-
Change in SF-36 scores
Time frame: Baseline and 12 week follow up
Quality of Life
-
Change in Pittsburgh Sleep Quality Index scores
Time frame: Baseline and 12 week follow up
Sleep patterns
-
Change in Gastrointestinal Symptom Rating Scale scores
Time frame: Baseline and 12 week follow up
Subjective gastrointestinal symptoms
-
Change in HbA1c and fasting glucose values
Time frame: Baseline and 12 week follow up
Laboratory measures of glycemic control
-
Change in C-reactive protein, Interleukin-6, and TNF-alpha values
Time frame: Baseline and 12 week follow up
Laboratory measures of inflammation
-
Change in Total Cholesterol, HDL, LDL, and VLDL values
Time frame: Baseline and 12 week follow up
Laboratory meausres of lipid levels
-
Change in waking cortisol levels
Time frame: Baseline and 12 week follow up
Laboratory measure of cortisol
-
Change in composition of the gut microbiome
Time frame: Baseline and 12 week follow up
Laboratory measure of gut microbiome
-
Change in oral microbiome composition
Time frame: Baseline and 12 week follow up
Laboratory measure of oral microbiome
Sponsors and collaborators
Lead sponsor
Kent State University
Other
Collaborators
- iHealth
Registry information
Official study title
Evaluation of a Probiotic on Psychological and Cognitive Effects in Middle and Older Adults
Important dates
- Study start
- 2017
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Mar 15, 2017
- Registry last updated
- Feb 20, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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