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

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

The purpose of the study is to evaluate the efficacy of a butyrate/polyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal discomfort.

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:

1. Male or female, age 25-70 years
2. Body mass index 18.5-34.9 kg/m2
3. 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
4. Experiencing at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, or constipation)
5. Healthy based on medical history and without chronic disease (unless permitted in the judgment of the PI/Sub-I)
6. Weight stable for the past six months (±6 lbs.)
7. Willing and able to give written informed consent
8. Ability to communicate and read in English
9. Ability to comply with study requirements

Exclusion Criteria:

1. Currently participating in another clinical research study
2. Pregnant, planning pregnancy, or breastfeeding
3. Unable to swallow capsules, tablets, or softgels
4. 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.
5. Typically goes longer than 3 days without a bowel movement
6. 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
7. Having had a medical or surgical event in the past 5 years involving hospitalization, outpatient, or emergency care that requires ongoing monitoring.
8. Planning to undergo a major medical procedure or surgical event within the next 30 days
9. Currently being treated for any infectious disease
10. 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)
11. Smoking or use of nicotine products daily within 30 days prior to screening
12. Using substances of abuse or recreational drugs/substances, including tetrahydrocannabinol (THC), within the past 14 days
13. 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)
14. Having donated blood or received a blood/plasma transfusion within 30 days before baseline
15. History of a major change in dietary habits within the past 1 month
16. Currently taking any supplements containing butyrate, tributyrin, or polyphenols and not willing to stop for the duration of study participation
17. Currently taking any laxatives on a daily basis
18. Initiated (Glucagon-Like Peptide-1) GLP-1 medication within 3 months prior to screening.
19. On a stable dose of a proton pump inhibitor (e.g., omeprazole, pantoprazole) within 3 months prior to screening.
20. History of oral or IV antibiotic use within the past 3 months prior to Baseline
21. 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
22. 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
23. Currently diagnosed with and/or being treated for Irritable Bowel Syndrome (IBS)
24. Currently experiencing or previously having a gastrointestinal infection (viral or bacterial) or food poisoning within the past month
25. Currently experiencing or previously having a parasitic infection within the past 3 months
26. Currently experiencing or having a history of severe endometriosis
27. History of gastrointestinal surgery, which might influence gastrointestinal function
28. 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 -