Bile Acid Supplement for Obesity

Overseen By Precision Medicine for Obesity

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must not be taking: Anti-obesity, Metformin, GLP-1 analogs

Disqualifiers: Gastrointestinal disorders, Pregnancy, Psychiatric, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Andres Acosta, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults aged 18-65 with obesity (BMI>30) and a 'hungry gut' phenotype. It includes those who are otherwise healthy or have controlled conditions like type 2 diabetes. Women must not be pregnant or breastfeeding, and all participants should not have gastrointestinal disorders, significant psychiatric dysfunction, substance abuse issues, or be on certain medications.

Inclusion Criteria

I am generally healthy or have well-managed chronic conditions like type 2 diabetes.

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

I am a man or a woman not pregnant or able to become pregnant.

Exclusion Criteria

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

Principal Investigator discretion

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the conjugated bile acid dietary supplement or placebo

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ileocolonic-release conjugated bile acid
• Placebo

Trial Overview Researchers are testing an ileocolonic-release conjugated bile acid supplement against a placebo to see its effects on cell function, hormones related to hunger and fullness ('satiety'), and body weight in obese individuals with abnormal satiety responses.

Participant Groups

Group I: Bile Acid Supplement Group Experimental Treatment 1 Intervention

Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements

Group II: Placebo Group Placebo Group 1 Intervention

Subjects with obesity and abnormal satiety phenotype will receive matching-placebo

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+