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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure, Body Composition, Immune Function
• Intervention / Treatment: Dietary supplement: Synbiotic, Probiotic, Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steve Ives, PhD; Phone Number: 5185808366; Email: sives@skidmore.edu

Study Locations

• United States
  • New York
    • Saratoga Springs, New York, United States, 12866
      • Recruiting
      • Skidmore College
      • Contact: Stephen Ives, Ph.D.; Phone Number: 518-580-8366; Email: sives@skidmore.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• To be included participants must be healthy, weight stable (± 4.4 lb for > 6 months prior), and 18 to 60 years of age. Participants will be expected to be relatively healthy without uncontrolled chronic disease (e.g. cardiovascular, metabolic, or pulmonary) and 1 or fewer positive risk factors for cardiovascular disease (e.g. high blood pressure, high cholesterol, etc.) as described by the American College of Sports Medicine/American Heart Association Criteria and presented in the table 1 below. Per College policy, participants who are visitors are required to be fully vaccinated against COVID-19, including a booster, and participants who are faculty, staff or students are required to be fully vaccinated against COVID-19 and receive a booster by January 24, 2022 or within 30 days of becoming eligible, unless a medical or religious exemption has been granted. Participants will be screened for eligibility by health history form in person baseline measurements are made (Figure 1). To ensure greater inclusion, ecological validity and representation, women will be included in this study; however, we will not control for menstrual cycle phase, but will document for possible statistical consideration.

Exclusion Criteria:

• Given the focus of the study those who are currently, or have recently used (<3 months), oral antibiotics or have diagnosed irritable bowel syndrome or gut/bowel maladies (short bowel syndrome, etc.) will be excluded. Subjects who present with 2 or more CVD risk factors (table above) or have uncontrolled/overt cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus), or recent blood donation (<8 weeks) will be excluded. Those who have cancer or are being treated for cancer will also be excluded. Women who are currently pregnant, breastfeeding, attempting to conceive, or amenorrheic (not associated with menopause or use of contraceptive medications) will also be excluded from the study. Anyone who is being treated for hypothyroid with levothyroxine will be excluded as one of the supplement ingredients, chromium polynicotinate, may interfere with this medication . Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment) will be excluded. Anyone recently diagnosed (<1yr) with an eating disorder or food allergies will also be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Synbiotic; 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)	Dietary supplement: Synbiotic, Probiotic, Placebo; Use of dietary supplements to improve gut microbiome and cardiometabolic health
Active Comparator: Probiotic; 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))	Dietary supplement: Synbiotic, Probiotic, Placebo; Use of dietary supplements to improve gut microbiome and cardiometabolic health
Placebo Comparator: Placebo; placebo control (4x/day collagen capsules and 2x/day placebo drink mixes (maltodextrin), Plexus)	Dietary supplement: Synbiotic, Probiotic, Placebo; Use of dietary supplements to improve gut microbiome and cardiometabolic health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Brachial and estimated central blood pressure	Baseline, 15 days, 30 days
Vascular Stiffness	Aortic vascular stiffness	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

Collaborators and Investigators

• Sponsor: Skidmore College
• Investigators: Principal Investigator: Stephen J Ives, PhD, Skidmore College

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2209-1044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be made available upon successful publication of the findings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No