Recruiting

Synbiotic vs. Probiotic

Sponsor:

Skidmore College

Code:

NCT06544915

Conditions

Blood Pressure, Body Composition, Immune Function

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Synbiotic, Probiotic, Placebo

Study Details

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

Study ID

NCT06544915

Start date

Jul 23, 2024

Status verified date

Aug, 2024

Completion date

Jan 1, 2025

Anticipated

Primary completion date

Jan 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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)

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))

placebo comparator: Placebo

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

Interventions

Synbiotic, Probiotic, Placebo

Use of dietary supplements to improve gut microbiome and cardiometabolic health

Primary outcome measure

  • Gut microbial diversity [ Time Frame: Baseline, 15 days, 30 days ]
  • Gut microbial count [ Time Frame: Baseline, 15 days, 30 days ]
  • Short Chain fatty acids [ Time Frame: Baseline, 15 days, 30 days ]

Central Contacts and Locations

Central contacts

Steve Ives, PhD

5185808366sives@skidmore.edu

Locations

Skidmore College

Recruiting

Saratoga Springs, New York, United States, 12866

Contacts

Stephen Ives, Ph.D.

518-580-8366sives@skidmore.edu

More Information

Sponsor

Skidmore College

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Skidmore College on 2024-08-09.