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

NCT ID: NCT06544915

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-23
• Study Completion Date: 2025-01-01

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Synbiotic, Probiotic, Placebo

Intervention Type: DIETARY_SUPPLEMENT

Use of dietary supplements to improve gut microbiome and cardiometabolic health

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))

Group Type: ACTIVE_COMPARATOR

Synbiotic, Probiotic, Placebo

Intervention Type: DIETARY_SUPPLEMENT

Use of dietary supplements to improve gut microbiome and cardiometabolic health

Placebo

placebo control (4x/day collagen capsules and 2x/day placebo drink mixes (maltodextrin), Plexus)

Group Type: PLACEBO_COMPARATOR

Synbiotic, Probiotic, Placebo

Intervention Type: DIETARY_SUPPLEMENT

Use of dietary supplements to improve gut microbiome and cardiometabolic health

Interventions

Synbiotic, Probiotic, Placebo

Use of dietary supplements to improve gut microbiome and cardiometabolic health

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Skidmore College

OTHER

Sponsor Role: lead

Responsible Party

Stephen J. Ives

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen J Ives, PhD

Role: PRINCIPAL_INVESTIGATOR

Skidmore College

Locations

Skidmore College

Saratoga Springs, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Steve Ives, PhD

Role: CONTACT

sives@skidmore.edu

5185808366

Facility Contacts

Stephen Ives, Ph.D.

Role: primary

sives@skidmore.edu

518-580-8366

References

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.

Reference Type: DERIVED

PMID: 39821451 (View on PubMed)

Other Identifiers

2209-1044

Identifier Type: -

Identifier Source: org_study_id