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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a bile acid supplement can aid in obesity management. It examines whether the supplement affects cellular function, alters hormones, and influences body weight. Participants will receive either the actual supplement, called ileocolonic-release conjugated bile acid, or a placebo (a harmless pill resembling the real one). Suitable candidates have a BMI over 30, often experience excessive hunger, and are otherwise healthy or have well-managed type 2 diabetes. As a Phase 1 trial, this research seeks to understand the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications to join the trial?

The trial requires that you stop taking certain medications, such as anti-obesity drugs and some diabetes medications like metformin or GLP-1 analogs, before joining. If you're on these medications, you would need to discontinue them to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that supplements like the one being studied, which release certain compounds in the gut, can positively impact body functions. These supplements may help the body manage sugar better by influencing specific gut cells, potentially benefiting people with obesity and diabetes in controlling their blood sugar levels.

However, the study is in its early stages, focusing primarily on assessing the treatment's safety for people. Detailed safety information from large groups may not yet be available. Testing in humans indicates that it has shown enough potential for further study. It is advisable to consult with the medical team conducting the trial to learn more about any possible side effects or risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, and sometimes surgery, this new bile acid supplement targets the way the body processes bile acids to influence appetite control. Researchers are excited because the ileocolonic-release conjugated bile acid works by potentially altering the gut environment and signaling pathways that regulate hunger, which is a novel approach compared to existing therapies. This method might offer a more direct way to affect satiety and metabolism without the side effects of traditional weight loss drugs.

What evidence suggests that this bile acid supplement could be an effective treatment for obesity?

Research has shown that delivering certain bile acids to the lower intestine can help control blood sugar in people with obesity. In this trial, participants in the Bile Acid Supplement Group will receive ileocolonic-release conjugated bile acid supplements. Studies have found that this treatment increases levels of GLP-1, a hormone that helps manage appetite and blood sugar. Specifically, participants taking these bile acid supplements had lower blood sugar levels after meals compared to those taking a placebo. This suggests that the supplements might aid weight control by affecting hormones that signal fullness and help manage blood sugar. These findings provide a promising basis for using this treatment to address issues related to obesity. ^{1 2 3 6 7}

Who Is on the Research Team?

Andres Acosta, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32344198/

Ileo-colonic delivery of conjugated bile acids ... - PubMed Ileo-colonic delivery of conjugated bile acids improves glucose homeostasis via colonic GLP-1-producing enteroendocrine cells in human obesity and diabetes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7186521/

Ileo-colonic delivery of conjugated bile acids improves ... FGF19 was decreased in obesity and diabetes compared to controls. When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, ...

3. thelancet.com thelancet.com/pdfs/journals/ebiom/PIIS2352-3964(20)30134-1.pdf

Ileo-colonic delivery of conjugated bile acids improves ... In this manuscript we proposed to answer three fundamental questions related to the bile acid pathway in human participants with obesity, with ...

4. researchgate.net researchgate.net/publication/340924566_Ileo-colonic_delivery_of_conjugated_bile_acids_improves_glucose_homeostasis_via_colonic_GLP-1-producing_enteroendocrine_cells_in_human_obesity_and_diabetes

Ileo-colonic delivery of conjugated bile acids improves ... FGF19 was decreased in obesity and diabetes compared to controls. When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352345X19300591

Metabolic Effects of Bile Acids: Potential Role in Bariatric ... Conjugated BAs released in the ileocolonic region in obese patients causes a statistically significant increase in postprandial GLP-1. GLP-2 is another ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20544350

Effect of Bile Acids on Satiety, Cell Function and Body ... The purpose of this study is to evaluate the effect of IC-CBAS 1000 mg BID on EEC function, weight loss, satiety perception, and satiety GI hormones, in ...

7. papers.ssrn.com papers.ssrn.com/sol3/papers.cfm?abstract_id=3517409

Ileo-Colonic Delivery of Conjugated Bile Acids Improves ... We studied the effect of ileo-colonic delivery of conjugated BAs (IC-CBAS) on glucose metabolism, incretins, and lipids, in participants with obesity and ...