Standard Process Heart and Gut Health Study

Stopped early · Not applicable

Conditions studied: Nutrition, Healthy

In brief

Key facts

Study ID: NCT05795946
Run by: Standard Process Inc.
People needed: 14
Starts: 2023-04-15
Expected to finish: 2024-12-31
Last updated by the study team: 2025-02-10

Who can join

Age: 25 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy participants (both male and female) aged 25-80 years with omnivorous diet (regular consumption of eggs, red meat, dairy)
No pre or probiotic consumption during study, no antibiotics during study
Moderate to high serum levels of TMAO (more than or equal to 4 uM) determined by a standard blood test
If the participant is on antibiotics, they should finish their medication and wait one month before testing for TMAO as a screening criterion
Normal blood pressure, non-smokers
Normal cholesterol
Participants can communicate and follow instructions
Participants voluntarily signed and dated an informed consent (ICF), reviewed by an Institutional Review Board (IRB), and provided authorization prior to any participation in the study
Participants who are willing to take nutritional supplements and have no known food allergies

You may not qualify if…

Vegan and vegetarian participants
Participants on medically prescribed diet
Participants not willing to stop consumption of fermented products (plain yogurt, kefir, kombucha, water kefir, miso, pickled vegetables, and sauerkraut) 2 weeks prior to the study start date and during the study timeline as this will interfere with gut microbiome related outcome assessment
Participants not willing to stop consuming polyphenols- green tea, cocoa, flaxseed, berries, and energy drinks
Participants who are currently or have participated in other interventional clinical trials in the last 4 weeks
Participants on certain supplements like GI health related (Probiotics, prebiotics, and/or antimicrobial botanicals), vitamin C, Choline, lecithin or L-carnitine, fish oil/krill oil containing supplements who don't wish to stop supplementation prior to 2 weeks of study start date
Participants who have any confirmed or suspected infectious disease (such as tuberculosis, Hepatitis B or C, HIV infection), malignancy, or any other clinically significant medical condition, which in the investigators' opinion, makes him or her not suitable for inclusion in the study*
Participants who have pacemakers, an implanted cardioverter defibrillator (ICD), or a cardiac resynchronization therapy device
Participants who have confirmed or suspected pregnancy (self-reported)
Participant waiting for a heart transplant
Participants currently hospitalized for acute myocardial infarction
Participants with a planned revascularization within 30 days of screening
Participants must not have any allergies to supplement ingredients (see list)
Participants who have initiated the use of prescription medications (defined as a medication that can be prescribed only by a properly authorized/licensed clinician), and not authorized non-prescription medications (over-the-counter medications), and other nutritional supplements
Participants who do not comply with all study requirements (including clinical visits)
Participants with high cholesterol or on lipid lowering medications like statins
Participants on following medication: NSAIDS, Steroids, Prednisone, Acid Reflux/GERD medicines: Tagamet, Zantac, Pepcid, Prilosec, Prevacid

Where it is running

Standard Process Nutrition Innovation Center — Kannapolis, North Carolina, United States

Full record on ClinicalTrials.gov

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