Clinical Trials Logo
  1. Home
  2. Gastrointestinal Discomfort
  3. NCT06397482

Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health

Healthy Clinical Trial

Official title:
A Single-Arm, Pilot Study to Assess the Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06397482
Study type Interventional
Source Kemin Foods LC
Contact
Status Completed
Phase N/A
Start date October 23, 2023
Completion date January 24, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1