Accordingly, the purpose of this study is to evaluate the efficacy of 1) supplementation with Synbiotic (Plexus® Triplex), 2) commercially-available Probiotic, or 3) placebo control over 30 days on the gut microbiome, cardiometabolic health, body weight and body composition in healthy individuals.
Specific Aim 1. Explore the changes in the gut microbiome using 16s rRNA sequencing to determine total bacterial counts, microbial diversity (alpha- and beta-diversity), short chain fatty acid (SCFA) concentration, circulating inflammatory biomarkers and mucosal immunity as a result of synbiotic vs. probiotic vs. placebo control. Specific Aim 2. Document the functional changes in cardiometabolic health-related parameters; specifically, heart rate, heart rate variability (HRV), blood pressure (central and peripheral), vascular stiffness (augmentation index, AIx, and pulse wave velocity, PWV), body weight and composition, blood glucose and lipids as a result of synbiotic vs. probiotic vs. placebo control. Specific Aim 3. Characterize the impact of synbiotic vs. probiotic vs. placebo control on perceptions of fullness/hunger, self-reported gastrointestinal health (questionnaire), and mood states. Hypothesis: We hypothesize that the synbiotic will result in greater changes in total gut bacterial count, microbial diversity, SCFA, while reducing circulating markers of inflammation and increasing determinants of mucosal immunity. Second, the synbiotic will result in greater enhancement of cardiometabolic health over the probiotic or placebo control. Third, the synbiotic will maintain or improve perceptual indicators of fullness/hunger, gastrointestinal health, and mood states over probiotic alone or placebo control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
60
Use of dietary supplements to improve gut microbiome and cardiometabolic health
Skidmore College
Saratoga Springs, New York, United States
RECRUITINGGut microbial diversity
alpha- and beta-diversity
Time frame: Baseline, 15 days, 30 days
Gut microbial count
Gut microbial species identification and quantification
Time frame: Baseline, 15 days, 30 days
Short Chain fatty acids
Short Chain Fatty Acid concentration
Time frame: Baseline, 15 days, 30 days
Blood pressure
Brachial and estimated central blood pressure
Time frame: Baseline, 15 days, 30 days
Vascular Stiffness
Aortic vascular stiffness
Time frame: Baseline, 15 days, 30 days
Vascular reactivity
Using the near-infrared vascular occlusion test
Time frame: Baseline, 15 days, 30 days
Heart Rate Variability
Time and frequency domain HRV parameters
Time frame: Baseline, 15 days, 30 days
Dietary Analysis
Dietary analysis using the ASA24 system
Time frame: Baseline, 15 days, 30 days
Body Composition
Body mass, % body fat using Tanita RD 545
Time frame: Baseline, 15 days, 30 days
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Blood Lipids
Blood lipid profile using Cholestech system
Time frame: Baseline, 15 days, 30 days
Salivary inflammation profile
Salimetrics ELISA for key inflammatory and immunity parameters (SIgA, IgG, alpha amylase, cortisol, c-reactive protein)
Time frame: Baseline, 15 days, 30 days