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

Mayo Clinic

Status and phase

Completed

Phase 1

Conditions

Healthy

Obesity

Treatments

Drug: Placebo

Dietary Supplement: Ileocolonic-release conjugated bile acid

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05314374

K23DK114460 (U.S. NIH Grant/Contract)

21-008310

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

I. Patients with obesity BMI> 30 kg/m2 and hungry gut phenotype.

II. Age: 18-65 years.

III. Gender: men or women. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope for the gastric emptying study.

IV. Otherwise healthy individuals or with controlled chronic medical conditions such as type 2 diabetes.

Exclusion criteria

I. Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. For screening the bowel disease questionnaire will be used to exclude subjects with irritable bowel syndrome.

II. Subjects with stool type Bristol classification 6-7 per bowel disease questionnaire.

III. Female subjects who are pregnant or breast-feeding.

IV. Use of anti-obesity medications upon screening (ie., orlistat, phentermine-topiramate, liraglutide, semaglutide, bupropion-naltrexone), metformin or GLP-1 analogs.

V. Individuals who are currently on treatment for unstable cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine, and psychiatric disease.

VI. Any acute or chronic condition or other disease that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.

VII. Significant untreated psychiatric dysfunction based upon screening. Hospital Anxiety and Depression Inventory (HAD) score >11 on depression scale, a self-administered alcoholism screening test (AUDIT-C) score >4 in men or >3 in women, and difficulties with substance or eating disorders determined by the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia); will mean the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. The provider will review the patient's alcohol intake over the past few months to confirm accuracy and determine study eligibility.

VII. Principal Investigator discretion.