This study is currently recruiting participants.
Number
001729-H
Sponsoring Institute
National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 99 Years
Referral Letter Required
No
Population Exclusion(s)
Fetuses;Children;Neonates;Adults who are or may become unable to consent;Pregnant Women
Keywords
Gut Barrier; Intestinal Health; PLASMA LIPIDS; Artherosclerosis; Low-Density Lipoprotein (LDL); Cholesterol; Lipoproteins; Human Milk Oligosaccharides (HMO); Gut Microbiota; Symbiotic
Recruitment Keyword(s)
None
Condition(s)
Healthy Volunteers
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Dietary Supplement: Cardiosyn
Supporting Site
National Heart, Lung, and Blood Institute
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.
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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.
-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.
Principal Investigator
Referral Contact
For more information: