Aging
Conditions
Keywords
Probiotic, Cognitive Function, Mood
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.
Interventions
DIETARY_SUPPLEMENTProbiotic - Lactobacillus Rhamnosus GG
2 capsules per day for 90 days
OTHERPlacebo
2 placebo capsules per day for 90 days
Sponsors
iHealth
Kent State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 Positive and Negative Affect Schedule | Baseline and 12 week follow up | Fluctuations in affect |
| 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 |
| Change in score on OECD Life Satisfaction scale (short) | Baseline and 12 week follow up | Subjective wellbeing - general |
| Change in score on Response to Stressful Events Scale | Baseline and 12 week follow up | Emotion regulation |
| Change in score on Connor-Davidson Resilience Scale | Baseline and 12 week follow up | Emotional resilience |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waking cortisol levels | Baseline and 12 week follow up | Laboratory measure of cortisol |
| Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores | Baseline and 12 week follow up | Memory |
| Change in oral microbiome composition | Baseline and 12 week follow up | Laboratory measure of oral microbiome |
| Change in composition of the gut microbiome | Baseline and 12 week follow up | Laboratory measure of gut microbiome |
| 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 SF-36 scores | Baseline and 12 week follow up | Quality of Life |
| Change in Pittsburgh Sleep Quality Index scores | Baseline and 12 week follow up | Sleep patterns |
| Change in Gastrointestinal Symptom Rating Scale scores | Baseline and 12 week follow up | Subjective gastrointestinal symptoms |
| 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 Total Cholesterol, HDL, LDL, and VLDL values | Baseline and 12 week follow up | Laboratory meausres of lipid levels |
Countries
United States
Outcome results
None listed