Evaluating the effects of synbiotics and probiotics on gut health and cardiometabolic factors

Evaluating the Effects of a Synbiotic Versus Probiotic or Placebo on Gut Microbiota and Cardiometabolic Health: A Randomized Double-Blind Placebo Controlled Trial

This study is testing whether a special blend of probiotics and prebiotics can improve gut health and heart-related factors in healthy people over 30 days.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Skidmore College (other)
• Locations: 1 site (Saratoga Springs, New York)
• Trial ID: NCT06544915 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy of a synbiotic supplement compared to a probiotic and a placebo over a 30-day period in healthy individuals. It will explore changes in the gut microbiome, including bacterial counts and diversity, as well as cardiometabolic health indicators such as blood pressure, body composition, and inflammatory markers. Participants will also report on their feelings of hunger, gastrointestinal health, and mood states. The study employs a randomized, double-blind, placebo-controlled design to ensure reliable results.

Who should consider this trial

Good fit: Ideal candidates are healthy individuals aged 18 to 60 who are weight stable and have minimal cardiovascular risk factors.

Not a fit: Patients with uncontrolled chronic diseases or multiple cardiovascular risk factors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved gut health and cardiometabolic outcomes for patients.

How similar studies have performed: Other studies have shown promising results with synbiotics and probiotics, suggesting potential benefits in gut and cardiometabolic health.

Eligibility criteria

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.

Where this trial is running

Saratoga Springs, New York

• Skidmore College — Saratoga Springs, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Stephen J Ives, PhD — Skidmore College
• Study coordinator: Steve Ives, PhD

Conditions: Blood Pressure, Body Composition, Immune Function