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Clinical Trials/NCT05314374
NCT05314374CompletedPhase 1

Effect of Ileocolic-released Conjugated Bile Acid on Satiety, Entero-Endocrine Cell Function, and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype

Mayo Clinic1 site in 1 country35 target enrollmentStarted: May 12, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
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

Experimental

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

Placebo Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andres J. Acosta, M.D., Ph.D.

Principal Investigator

Mayo Clinic

Study Sites (1)

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