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

NCT06544915 | Recruiting

• 1 other identifier: 2209-1044
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure, Body Composition, Immune Function

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Blood pressure

  Baseline, 15 days, 30 days

• Vascular Stiffness

  Baseline, 15 days, 30 days

• Vascular reactivity

  Baseline, 15 days, 30 days

• Heart Rate Variability

  Baseline, 15 days, 30 days

• Dietary Analysis

  Baseline, 15 days, 30 days

Study Arms (3)

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)

Dietary Supplement: Synbiotic, Probiotic, Placebo

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))

Dietary Supplement: Synbiotic, Probiotic, Placebo

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Synbiotic, Probiotic, Placebo

Interventions

Synbiotic, Probiotic, Placebo DIETARY_SUPPLEMENT

Use of dietary supplements to improve gut microbiome and cardiometabolic health

Placebo; Probiotic; Synbiotic

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Skidmore College: lead

Study Sites (1)

Skidmore College

Saratoga Springs, New York, 12866, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39821451 DERIVED

MeSH Terms

Interventions

Synbiotics; Probiotics

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Stephen J Ives, PhD

  Skidmore College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steve Ives, PhD

CONTACT

5185808366; sives@skidmore.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Actives and placebos made by 3rd party in discreet containers inconspicuously labeled.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized placebo-controlled double-blind parallel study

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: July 23, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

US (1)