Status:
TERMINATED
Healthy Volunteer Short Chain Fatty Acid Study
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the production of short chain fatty acids (fatty acids are part of your diet) in stool through the measurement of fecal inulin after a one-time ingestion of 10...
Detailed Description
The Study involves 2 visits and will include 3 types of subjects. Any healthy adult between the ages of 18 and 75 with no prior history of GI disease or symptoms is eligible to participate in the stud...
Eligibility Criteria
Inclusion
- Healthy adults ages 18-75 years with no prior history of GI disease or symptoms.
- Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low fermentable oligo-, di-, monosaccharides, and polyols diet (FODMAP) diet at the time of study participation
Exclusion
- History of microscopic colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated aspartate transaminase/alanine transaminase \> 2.0x the upper limit of normal
- Prior therapy of the abdomen or abdominal surgeries with the exception of appendectomy or cholecystectomy \> 6 months prior to study initiation
- Ingestion of any prescription, over the counter, or herbal medications which can affect study interpretation within 6 months of study initiation for asymptomatic volunteers. Rescue therapy to facilitate stool collection will be permitted where needed.
- Any females who are pregnant or breast-feeding
- Antibiotic usage within 3 months prior to study participation
- Prebiotic or probiotic usage within the 2 weeks prior to study initiation
- Inulin usage within the 2 weeks prior to study initiation
- Use of tobacco products within the past 6 months
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05254340
Start Date
August 1 2021
End Date
July 31 2023
Last Update
September 25 2024
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202