NCT06544915

Evaluating the Effects of a Synbiotic Versus Probiotic or Placebo on Gut Microbiota and Cardiometabolic Health: A Randomized Double-Blind Placebo Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Skidmore College · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Blood Pressure, Body Composition, Immune Function

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Synbiotic, Probiotic, Placebo	Use of dietary supplements to improve gut microbiome and cardiometabolic health

Timeline

• Start date: 2024-07-23
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: United States