Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544915
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Evaluating the Effects of a Synbiotic Versus Probiotic or Placebo on Gut Microbiota and Cardiometabolic Health A Randomized Double-Blind Placebo Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GUTRCT
Brief 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 fullnesshunger 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 fullnesshunger gastrointestinal health and mood states over probiotic alone or 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 fullnesshunger 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 fullnesshunger gastrointestinal health and mood states over probiotic alone or placebo control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None