Recruiting
Early Phase 1

Synbiotic Supplement

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT06615986

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Cardiosyn

Study Details

Brief summary:

Background:

Human intestines are home to a complex gut flora, also called microbiome; this is a natural occurring community of bacteria, fungi, yeast, and viruses. Changes in the balances of the gut flora can lead to illnesses, such as diabetes, colorectal cancer, and inflammatory bowel diseases. Synbiotics are dietary supplements people take to maintain proper balances of their gut flora aiming to improve health.

Objective:

To find out if a synbiotic supplement can increase the type and amount of beneficial gut bacteria in healthy people as well as improve cardio-vascular protection markers. The supplement contains a natural sugar from human milk.

Eligibility:

Healthy people aged 18 years or older who eat a typical western diet. They must take no medications (with a few exceptions).

Design:

Participants will have 2 clinic visits.

The first visit will start with screening. They will have a blood test and wait around 2 hours for the results of the blood test. The test will determine if they are eligible for the study.

Eligible participants will have additional blood drawn during the screening visit. They will be given a kit to collect a stool sample at home with instructions. They may complete a 3-day food diary. They will meet with a nutritionist and a physician by phone, telehealth, or in person.

The supplement is a powder that is mixed with water or another noncarbonated drink. Participants will drink 2 doses per day. Each dose will be 1 hour before or after a meal.

The second visit will be about 8 weeks after the first. Participants may repeat the 3-day food diary and nutrition visit. The physical exam, blood tests, and stool sample will be repeated.

Conditions

Healthy Volunteers

Study ID

NCT06615986

Start date

Nov 15, 2024

Status verified date

Jun 11, 2026

Completion date

May 15, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cardiosyn in Healthy Volunteers

Participants will receive 2 doses of Cardiosyn daily by mouth (2 sachets) for a total of 16.2 grams. Each does (sachet) is 8.1 grams.

Interventions

Cardiosyn

Two sachets by mouth daily. Each dose (sachet) is 8.1 grams. For 2 doses it will be 16.2 grams per person per day.

Primary outcome measure

  • Mean change in population of Lactobacillus plantarum and Bifidobacterium bifidum [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Jun 16, 2026

Last verified

Jun 11, 2026

Keywords

  • Gut Barrier
  • Intestinal Health
  • PLASMA LIPIDS
  • Artherosclerosis
  • Low-Density Lipoprotein (LDL)
  • Cholesterol
  • Lipoproteins
  • Human Milk Oligosaccharides (HMO)
  • Gut Microbiota
  • Symbiotic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-06-16.