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Bile Acid Supplement

Bile Acid Supplement for Obesity

Phase 1
Waitlist Available
Led By Andres Acosta, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 18-65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights

Study Summary

This trial is testing whether a bile acid supplement can help with weight loss by improving cell function and hormones.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the specific side effects of the bile acid supplement aren't detailed here, potential risks may include digestive discomfort or changes in bowel habits given it targets gut function. Placebo typically has no active ingredients but can cause perceived side effects due to expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enteroendocrine L cell (EEC) function

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bile Acid Supplement GroupExperimental Treatment1 Intervention
Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects with obesity and abnormal satiety phenotype will receive matching-placebo

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,047 Total Patients Enrolled
84 Trials studying Obesity
14,687 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,150 Total Patients Enrolled
446 Trials studying Obesity
588,902 Patients Enrolled for Obesity
Andres Acosta, MD, PhDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
95 Total Patients Enrolled
1 Trials studying Obesity
80 Patients Enrolled for Obesity

Media Library

Ileocolonic-release conjugated bile acid (Bile Acid Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05314374 — Phase 1
Obesity Research Study Groups: Bile Acid Supplement Group, Placebo Group
Obesity Clinical Trial 2023: Ileocolonic-release conjugated bile acid Highlights & Side Effects. Trial Name: NCT05314374 — Phase 1
Ileocolonic-release conjugated bile acid (Bile Acid Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05314374 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned ileocolonic-release conjugated bile acid for therapeutic use?

"Our assessment of Ileocolonic-release conjugated bile acid's safety is 1, given its Phase 1 status and lack of significant data regarding efficacy."

Answered by AI

Does this research program accept participants who are 45 or older?

"The enrolment age range for this medical trial is 18 to 65, in accordance with the established criteria."

Answered by AI

Are there any available vacancies among the participants of this experiment?

"Per clinicaltrials.gov, this medical trial is no longer accepting patients since its last update on May 31st 2022. Although it has ceased recruitment of participants, there are 1,870 additional trials currently enrolling individuals."

Answered by AI

Is it possible for me to participate in this clinical investigation?

"This clinical trial is searching for 36 individuals between 18 to 65 years old who are classified as obese (BMI > 30 kg/m^2) and possess a hungry gut phenotype. Furthermore, candidates must be of any gender with the caveat that women of childbearing potential need to take a pregnancy test before initiating medication or within 48 hours post-administration of radioisotope. The last criterion requires participants to have no other health complications besides type 2 diabetes if it has been managed properly."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype
Andres J. Acosta, M.D., Ph.D. 2023. "Effect of Bile Acids on Satiety, Cell Function and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05314374.
~24 spots leftby May 2026
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