Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397482
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2024-04-17
Brief Title:
Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health
Sponsor:
Kemin Foods LC
Organization:
Kemin Foods LC
Study Overview
Official Title:
A Single-Arm Pilot Study to Assess the Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg gasflatulence and abdominal bloating bowel habits frequency and consistency digestion-associated quality of life and measures of GI permeability
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None