Healthy Clinical Trial
Official title:
A Single-Arm, Pilot Study to Assess the Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health
The primary objective of this single-arm pilot study is to investigate the effects of an encapsulated calcium butyrate dietary supplement on gastrointestinal (GI) health outcomes in healthy adults, including GI symptom severity (e.g., gas/flatulence and abdominal bloating), bowel habits (frequency and consistency), digestion-associated quality of life, and measures of GI permeability.
This will be a single-arm pilot study consisting of one screening visit (day -8) and four intervention visits (days 0, 1, 43, and 44). On visit 1 (day -8), subjects will arrive at the clinic in a fasting state. After providing voluntary informed consent, subjects will undergo a medical history evaluation along with clinic visit procedures. Blood samples will be collected for safety analyses. Subjects will complete the Gastrointestinal Symptom Rating Scale (GSRS) and the Diet ID questionnaire. A Bowel Habits Diary (BHD) and stool collection kit will be dispensed to complete prior to visit 2. On visit 2 (day 0), subjects will arrive at the clinic in a fasting state and undergo clinic visit procedures. Fecal samples and the BHD from visit 1 will be collected. Subjects will be administered the GSRS for determination of eligibility (at least mild symptoms of indigestion at visit 1 and 2). Enrolled participants will be administered the Digestion-associated Quality of Life Questionnaire (DQLQ). Blood samples will be collected for markers of intestinal permeability. Subjects will then complete an intestinal permeability test where they will ingest two sugar probes and be instructed to collect all urine over the following 24 h. A BHD and stool collection kit will be dispensed to complete prior to visit 4. Study product and a study product log will be dispensed. On visit 3 (day 1), subjects will arrive at the clinic to return their urine collection containers. On visit 4 (day 43), subjects will arrive at the clinic in a fasting state and undergo clinic visit procedures. Fecal samples and the BHD from visit 2 will be collected. Subjects will be administered the GSRS and DQLQ. Blood samples will be collected for safety analyses and markers of intestinal permeability. Subjects will then complete an intestinal permeability test as previously described. The study product log and unused study product will be collected. On visit 5 (day 44), subjects will arrive at the clinic to return their urine collection containers. Subjects will receive an email link for an electronic GSRS and DQLQ to be completed on days 8, 15, 22, 29, and 36. ;
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