Supplement to improve gut health and cardiovascular markers
Evaluation of a Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
This study is testing a new supplement made from human milk ingredients to see if it can improve gut health and heart-related markers in healthy adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06615986 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of a human milk oligosaccharide-based synbiotic supplement called Cardiosyn on gut microbiota and cardiovascular health in healthy adults. Participants will undergo screening and blood tests to assess their eligibility, followed by two clinic visits to monitor changes in gut bacteria and various health markers. The primary goal is to increase beneficial gut bacteria, specifically Lactobacillus Plantarum and Bifidobacterium Bifidum, while also evaluating the supplement's impact on gut integrity and plasma biomarkers.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 years or older who consume a typical western diet and are not on any medications.
Not a fit: Patients who are pregnant, breastfeeding, or following a vegetarian or vegan diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this supplement could enhance gut health and improve cardiovascular protection markers in healthy individuals.
How similar studies have performed: Other studies have shown promising results with synbiotic approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Healthy males and females between the ages 18 to 99. * Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations. * Subjects taking no medications, with a few exceptions (sporadic medication and medications known to not significantly affect the microbiome, per PI discretion). * Screening labs within normal levels. Deviations of the screening labs from normal levels up to CTCAE v5, grade 1 are allowed per PI discretion. EXCLUSION CRITERIA: * Pregnancy or women currently breastfeeding. * Subjects currently on other prebiotics and/or probiotics supplementation. * Subjects that are vegetarians or vegans or not on a typical western diet. * Subjects planning to initiate new medications or already taking medications that may interfere or modify gut microbiome. * Subjects with allergy or known hypersensitivity to any components of the supplement. * Subjects with weight changes greater than 20% over the past 3 months. * Subjects planning a significant change in diet or exercise levels. * Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption. * Anticipated surgery during the study period. * Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Marcelo J Amar, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Joy Lynne V Freeman
- Email: joylynne.freeman@nih.gov
- Phone: (301) 480-7632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.