A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms

This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a butyrate/polyphenol formulation on gut health and associated symptoms in healthy individuals.

Participants will be asked to complete a laboratory assessment and questionnaires. A total of up to 124 subjects (62 subjects per arm) will be enrolled for the 14-day period. Laboratory testing will include an assessment of the Gut Microbiome.

Inclusion criteria

• Male or female, age 25-70 years
• Body mass index 18.5-34.9 kg/m2
• A GSRS-IBS score ≥ 21 (identification as having moderate or severe gastrointestinal symptoms). If the GSRS-IBS score is < 20 (identification of minimal or mild), may be included at the discretion of the PI/Sub-I
• Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation)
• Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI/Sub-I)
• Weight stable for the past six months (±6 lbs.)
• Willing and able to give written informed consent
• Ability to communicate and read in English
• Ability to comply with study requirements

Exclusion criteria

• Currently participating in another clinical research study
• Pregnant, planning pregnancy, or breastfeeding
• Unable to swallow capsules, tablets, or softgels
• Male participants and females of childbearing potential who are unwilling to use an acceptable method of contraception from screening through 30 days after study completion.
• Typically goes longer than 3 days without a bowel movement
• Current diagnosis of cardiovascular disease, history of an abnormal electrocardiogram (ECG), diabetes (Type 1 or Type 2), or cancer (except for non-melanoma skin cancer) within the past 5 years
• Having had a medical or surgical event in the past 5 years involving hospitalization, outpatient, or emergency care that requires ongoing monitoring.
• Planning to undergo a major medical procedure or surgical event within the next 30 days
• Currently being treated for any infectious disease
• Currently consuming more than 6 standard alcoholic drinks per week for women and 10 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor)
• Smoking or use of nicotine products daily within 30 days prior to screening
• Using substances of abuse or recreational drugs/substances, including tetrahydrocannabinol (THC), within the past 14 days
• History of intolerance or allergic reaction to product ingredients, including butyrate, tributyrin, polyphenols (Green tea extract, Grape Seed extract, Cinnamon extract, maltodextrin, silicon dioxide, magnesium stearate, or chlorophyllin)
• Having donated blood or received a blood/plasma transfusion within 30 days before baseline
• History of a major change in dietary habits within the past 1 month
• Currently taking any supplements containing butyrate, tributyrin, or polyphenols and not willing to stop for the duration of study participation
• Currently taking any laxatives on a daily basis
• Initiated (Glucagon-Like Peptide-1) GLP-1 medication within 3 months prior to screening.
• On a stable dose of a proton pump inhibitor (e.g., omeprazole, pantoprazole) within 3 months prior to screening.
• History of oral or IV antibiotic use within the past 3 months prior to Baseline
• Not willing to refrain from taking any over-the-counter medications or supplements for gastrointestinal concerns or discomfort (except if on a stable dose for > 3 months before Screening and unlikely to change) unless in the judgment of the PI/Sub-I
• Current or previous history of medically diagnosed and treated gastrointestinal disease, including gallbladder problems, gallstones, biliary obstruction, inflammatory bowel disease (IBD), Crohn's disease, Ulcerative Colitis, Celiac disease, or gastrointestinal cancer
• Currently diagnosed with and/or being treated for Irritable Bowel Syndrome (IBS)
• Currently experiencing or previously having a gastrointestinal infection (viral or bacterial) or food poisoning within the past month
• Currently experiencing or previously having a parasitic infection within the past 3 months
• Currently experiencing or having a history of severe endometriosis
• History of gastrointestinal surgery, which might influence gastrointestinal function
• History or presence of a clinically significant diagnosis or circumstance that, in the judgment of the Study Investigator/Sub-I, would interfere with the interpretation of the study results and preclude participation in the study -