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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synbiotic | Experimental | synbiotic (Triplex (2x/day Probiotic capsules (2 billion CFU/capsule, ProBio5), 2x/day Capsules of gut supporting micronutrients; magnesium, vitamin c and citrus bioflavonoids (BioCleanse) and 2x/day Pre-biotic drink mixes (Slim Microbiome Activating), Plexus®, Scottsdale, AZ, USA) |
|
| Probiotic | Active Comparator | probiotic (2x/day probiotic capsules (2 billion CFU/capsules, NOW supplement), 2x/day capsules of collagen (Plexus), and 2x/day placebo drink mixes of corn-based maltodextrin (Plexus)) |
|
| Placebo | Placebo Comparator | placebo control (4x/day collagen capsules and 2x/day placebo drink mixes (maltodextrin), Plexus) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic, Probiotic, Placebo | Dietary Supplement | Use of dietary supplements to improve gut microbiome and cardiometabolic health |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbial diversity | alpha- and beta-diversity | Baseline, 15 days, 30 days |
| Gut microbial count | Gut microbial species identification and quantification | Baseline, 15 days, 30 days |
| Short Chain fatty acids | Short Chain Fatty Acid concentration | Baseline, 15 days, 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Brachial and estimated central blood pressure | Baseline, 15 days, 30 days |
| Vascular Stiffness | Aortic vascular stiffness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steve Ives, PhD | Contact | 5185808366 | sives@skidmore.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephen J Ives, PhD | Skidmore College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skidmore College | Recruiting | Saratoga Springs | New York | 12866 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39821451 | Derived | Lang JM, Shostak ES, Quinn WK, Chervinskaya VD, Fioraso E, Smith E, Kotarsky CJ, DeBlauw JA, Lloyd JL, Ives SJ. Dyslipidemia Impacts Cardiometabolic Health and CVD Risk in a Relatively Young Otherwise Healthy Population. J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14972. doi: 10.1111/jch.14972. |
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IPD will be made available upon successful publication of the findings.
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Randomized placebo-controlled double-blind parallel study
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Actives and placebos made by 3rd party in discreet containers inconspicuously labeled.
| Baseline, 15 days, 30 days |
| Vascular reactivity | Using the near-infrared vascular occlusion test | Baseline, 15 days, 30 days |
| Heart Rate Variability | Time and frequency domain HRV parameters | Baseline, 15 days, 30 days |
| Dietary Analysis | Dietary analysis using the ASA24 system | Baseline, 15 days, 30 days |
| Body Composition | Body mass, % body fat using Tanita RD 545 | Baseline, 15 days, 30 days |
| Blood Lipids | Blood lipid profile using Cholestech system | Baseline, 15 days, 30 days |
| Salivary inflammation profile | Salimetrics ELISA for key inflammatory and immunity parameters (SIgA, IgG, alpha amylase, cortisol, c-reactive protein) | Baseline, 15 days, 30 days |
| ID | Term |
|---|---|
| D058616 | Synbiotics |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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