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COMPLETED

NCT07515443

The Effects of a Commercially Available Synbiotic on the Gut Microbiome and Cardiometabolic Health

Sponsor: Southern Utah University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-01

Completion Date

2025-12-31

Last Updated

2026-07-29

Healthy Volunteers

Yes

Conditions

Hypertension Gut Dysbiosis Overweight , Obesity

Interventions

DIETARY_SUPPLEMENT

Synbiotic

daily supplementation of snybiotic drink packet and capsule of multistrain probiotic

DIETARY_SUPPLEMENT

Placebo

daily placebo drink packet and capsule

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, attempting to conceive, or amenorrheic (not associated with menopause or use of contraceptive medications) will also be excluded from the study. * Anyone with severe illness or compromised or suppressed immune system (e.g. taking immunosuppressants, chronic viral infection or treatment) will be excluded \[20\]. Anyone recently diagnosed (\<1yr) with an eating disorder will also be excluded. * Finally, anyone with food allergies should be cautioned but those with known sensitivity to wheat, acacia gum, stevia, maltodextrin, or rice flour should not participate and will be excluded.

Locations (1)

Southern Utah University

Cedar, Utah, United States