CompletedNot Applicable

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

United States47 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 2 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 \[18\] and presented in the table 1 below. Participants will be screened for eligibility by a health history form (Appendix A) in person before 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 the 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 \[19\]. Subjects who present with more than 2 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, a…

What they're measuring

Gut microbiome diversity and total bacteria

Timeframe: 30 days

Blood biomarkers

Timeframe: 30 days

Trial details

NCT IDNCT07515443

SponsorSouthern Utah University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31