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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
200
2 capsules per day for 90 days
2 placebo capsules per day for 90 days
Kent State Uniersity
Kent, Ohio, United States
Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R)
Depressive symptoms
Time frame: Baseline and 12 week follow up
Change in score on State-Trait Anxiety Inventory
Anxiety symptoms
Time frame: Baseline and 12 week follow up
Change in score on Perceived Stress Scale
Subjective stress
Time frame: Baseline and 12 week follow up
Change in score on Positive and Negative Affect Schedule
Fluctuations in affect
Time frame: Baseline and 12 week follow up
Change in score on Profile of Mood States
Fluctuations in affect - acute
Time frame: Baseline and 12 week follow up
Change in score on Warwick-Edinburgh Mental Well-Being Scale
Subjective wellbeing
Time frame: Baseline and 12 week follow up
Change in score on OECD Life Satisfaction scale (short)
Subjective wellbeing - general
Time frame: Baseline and 12 week follow up
Change in score on Response to Stressful Events Scale
Emotion regulation
Time frame: Baseline and 12 week follow up
Change in score on Connor-Davidson Resilience Scale
Emotional resilience
Time frame: Baseline and 12 week follow up
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Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores
Memory
Time frame: 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
Time frame: Baseline and 12 week follow up
Change in Pattern Comparison Processing Speed Test scores
Processing Speed
Time frame: Baseline and 12 week follow up
Change in SF-36 scores
Quality of Life
Time frame: Baseline and 12 week follow up
Change in Pittsburgh Sleep Quality Index scores
Sleep patterns
Time frame: Baseline and 12 week follow up
Change in Gastrointestinal Symptom Rating Scale scores
Subjective gastrointestinal symptoms
Time frame: Baseline and 12 week follow up
Change in HbA1c and fasting glucose values
Laboratory measures of glycemic control
Time frame: Baseline and 12 week follow up
Change in C-reactive protein, Interleukin-6, and TNF-alpha values
Laboratory measures of inflammation
Time frame: Baseline and 12 week follow up
Change in Total Cholesterol, HDL, LDL, and VLDL values
Laboratory meausres of lipid levels
Time frame: Baseline and 12 week follow up
Change in waking cortisol levels
Laboratory measure of cortisol
Time frame: Baseline and 12 week follow up
Change in composition of the gut microbiome
Laboratory measure of gut microbiome
Time frame: Baseline and 12 week follow up
Change in oral microbiome composition
Laboratory measure of oral microbiome
Time frame: Baseline and 12 week follow up