NCT05314374CompletedPhase 1
Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype
Effect of Ileocolic-released Conjugated Bile Acid on Satiety, Entero-Endocrine Cell Function, and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype
Source: ClinicalTrials.gov · Last updated 4 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 10 Feb 2022
- Start date
- 12 May 2023
- Primary completion date
- 22 Mar 2024
- Lead sponsor
- Mayo Clinic
- Diseases
- Obesity
- NCT number
- NCT05314374
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 35
- From 12 May 2023 to the primary completion date, 22 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of anti-obesity medications upon screening (ie., orlistat, phentermine-topiramate, liraglutide, semaglutide, bupropion-naltrexone), metformin or GLP-1 analogs.
- Individuals who are currently on treatment for unstable cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine, and psychiatric disease.
Other illness
- 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.
- Subjects with stool type Bristol classification 6-7 per bowel disease questionnaire.
- 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.
- 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.
Other
- Female subjects who are pregnant or breast-feeding.
- Principal Investigator discretion.
Who the study is looking for
- Patients with obesity BMI\> 30 kg/m2 and hungry gut phenotype.
- Age: 18-65 years.
- 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.
- Otherwise healthy individuals or with controlled chronic medical conditions such as type 2 diabetes.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.