Effect of Ileocolic-released Conjugated Bile Acid on Satiety, Entero-Endocrine Cell Function, and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Glucagon-Like Peptide-1 (GLP-1)
Study Overview
Brief Summary
The purpose of this research is to study the effect of the study drug (a conjugated bile acid dietary supplement) or placebo on cell function, hormones and body weight.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Bile Acid Supplement Group
Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements
Intervention: Ileocolonic-release conjugated bile acid (Dietary Supplement)
Placebo Group
Subjects with obesity and abnormal satiety phenotype will receive matching-placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Glucagon-Like Peptide-1 (GLP-1)
Time Frame: 90 days
The number of participants that provided a blood sample for GLP-1 (ug/ml) .
Peptide Trosin Tyrosine (PYY) Hormone
Time Frame: 90 days
The number of participants that provided a blood sample for PYY.
Secondary Outcomes
- Change in Weight(Baseline, 12 weeks)
Investigators
Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Mayo Clinic