MedTrace Logo

The Effects of a Commercially Available Synbiotic on the Gut Microbiome and Cardiometabolic Health: A Randomized Double-Blind Placebo-Controlled Trial

NCT07515443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-04-07

No results posted yet for this study

Summary

The purpose of this study is to see the effect of 30 days of synbiotic vs. probiotic supplementation (usingJuice+ nutrition products) on body weight, metabolism, cardiovascular health, and gut health. This study will provide information for future studies and how such supplementation might influence health long term. You are being asked to participate because you are 18-60 years old, relatively healthy 1 or fewer risk factors for cardiovascular disease), and have been weight stable (weight within ±4.4 lbs) for at least 6 months.People who present with 2 or more cardiovascular disease risk factors (we will ask you this information) or have uncontrolled/overt cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus), or recent blood donation (\<8 weeks) will not be able to participate. Those who have been diagnosed and/or are being treated for cancer will not be able to participate. Anyone recently (\<1yr) diagnosed with an eating disorder is also not eligible to participate. Women who are currently pregnant, breastfeeding, attempting to conceive, or without a period will not be allowed to participate. 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. 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 Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment) will be excluded. Please discuss any other potential food allergies with the research team, as food allergies will disqualify you from participating. About 48 people will take part in this research.

Conditions

Interventions

DIETARY_SUPPLEMENT

Synbiotic

daily supplementation of snybiotic drink packet and capsule of multistrain probiotic

DIETARY_SUPPLEMENT

Placebo

daily placebo drink packet and capsule

Sponsors & Collaborators

  • Southern Utah University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07515443 on ClinicalTrials.gov