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

NCT07515443 | Completed

• 1 other identifier: 30-052025a
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension; Gut Dysbiosis; Overweight , Obesity

Outcome Measures

Primary Outcomes (2)

• Gut microbiome diversity and total bacteria

  Explore the changes in the gut microbiome using 16s rRNA sequencing to determine total bacterial counts, microbial diversity (alpha- and beta-diversity).

  30 days

• Blood biomarkers

  Blood markers of short chain fatty acid (SCFA) concentration, circulating inflammatory biomarkers and mucosal immunity

  30 days

Secondary Outcomes (1)

• Hypertension

  30 days

Study Arms (2)

Treatment group

EXPERIMENTAL

30 day supplementation of synbiotic

Dietary Supplement: Synbiotic

Control group

PLACEBO COMPARATOR

30 day supplementation of placebo

Dietary Supplement: Placebo

Interventions

Synbiotic DIETARY_SUPPLEMENT

daily supplementation of snybiotic drink packet and capsule of multistrain probiotic

Treatment group

Placebo DIETARY_SUPPLEMENT

daily placebo drink packet and capsule

Control group

Eligibility Criteria

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

You may qualify if:

• 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).

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 \[19\].
• 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.

Sponsors & Collaborators

• Southern Utah University: lead

Study Sites (1)

Southern Utah University

Cedar, Utah, 84721, United States

Location

MeSH Terms

Conditions

Hypertension; Overweight; Obesity

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

US (1)