Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients with Obesity and Abnormal Satiety Phenotype

Phase 1

• Conditions: Healthy; Obesity
• Interventions: Drug: Placebo; Dietary Supplement: Ileocolonic-release conjugated bile acid

• Registration Number: NCT05314374
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-06
• Study Start: 2023-05-12
• Primary Completion: 2024-03-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Subjects with obesity and abnormal satiety phenotype will receive matching-placebo
Bile Acid Supplement Group	Ileocolonic-release conjugated bile acid	Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements

Primary Outcome Measures

Name	Time	Method
Enteroendocrine L cell (EEC) function	up to 90 days	Change in postprandial GLP-1 (ug/ml)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States