Status:
COMPLETED
Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
North Carolina Translational and Clinical Sciences Institute
Conditions:
Intestinal Health
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This study aims to establish the safety of a 15 g/day dose of pure prebiotics ß(1-4) galacto-oligosaccharides (GOS) and GOS enriched with N-Acetyl-D-lactosamine, a building block of gut glycoproteins ...
Eligibility Criteria
Inclusion
- All participants will be nonsmokers and well-nourished according to standard anthropometric criteria with BMI between 18.5 and 32.
- Individuals must be able to give informed consent.
- Subjects willing and able to:
- consume prebiotics or placebo preparations for a period of 4 weeks.
- Record daily food consumption using the Centers for Disease Control and Prevention (CDC) My Food Diary questionnaire.
- provide stool and blood (via venipuncture) samples.
- Enrollment will not be restricted based on race, ethnicity, or gender. The subject population will reflect the population providing a broad selection of individuals to allow enrollment of subjects from all races, ethnicities, and genders, as represented in North Carolina state.
Exclusion
- Less than 18 years of age or older than 55 years of age
- Pregnant or breastfeeding
Key Trial Info
Start Date :
June 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2025
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06068894
Start Date
June 13 2024
End Date
March 26 2025
Last Update
May 23 2025
Active Locations (1)
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1
UNC-Chapel Hill
Chapel Hill, North Carolina, United States, 27599