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Cardiosyn Supplement for Gut Bacteria in Healthy Adults

This study is looking at whether a dietary supplement called Cardiosyn can improve the balance of gut bacteria in healthy adults. Cardiosyn contains a natural sugar found in human milk, along with prebiotics and probiotics. Researchers want to see if taking two sachets (8.1 grams each) of Cardiosyn by mouth daily for 8 weeks can increase specific beneficial bacteria, *Lactobacillus plantarum* and *Bifidobacterium bifidum*, in your gut. They also want to see if it affects markers related to heart health. You might be able to join if you are a healthy adult between 18 and 99 years old and take very few medications. The study aims to enroll 100 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 100 healthy volunteers. It is a pilot proof-of-principle study.
What's involved
You would take two sachets of Cardiosyn by mouth daily. The study measures changes in gut bacteria at 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06615986

Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

Recruiting
EARLY_PHASE1Ages 18–99InterventionalBasic science
National Heart, Lung, and Blood Institute (NHLBI)
~100 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Cardiosyn

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in population of Lactobacillus plantarum and Bifidobacterium bifidum
Measured over 8 weeks

Conditions

Healthy Volunteers

Explore related trials

Healthy Volunteers

NCT06615986

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Marcelo J Amar, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)

Who to contact

Joy Lynne V Freeman
[email protected]
(301) 480-7632
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Mean change in population of Lactobacillus plantarum and Bifidobacterium bifidum8 weeks

    To assess changes in the microbiome, we will measure the increase in the populations of Lactobacillus plantarum and Bifidobacterium bifidum.