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

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05314374
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
36
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Ileocolonic-release conjugated bile acid
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Ileocolic-released Conjugated Bile Acid on Satiety, Entero-Endocrine Cell Function, and Body Weight in Patients With Obesity and Abnormal Satiety Phenotype
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bile Acid Supplement Group

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

Dietary Supplement: Ileocolonic-release conjugated bile acid
1000mg tablets orally twice a daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 4 days
Other Names:
  • IC-CBAS

    		•
    Placebo Comparator: Placebo Group

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

    Drug: Placebo
    Placebo looks exactly like the study drug, but it contains no active ingredient. 1000mg tablets orally twice a daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 4 days.
    Other Names:
  • Matching-placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Enteroendocrine L cell (EEC) function [up to 90 days]

      Change in postprandial GLP-1 (ug/ml)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Willing to provide consent.

    • Patients with obesity BMI> 30 kg/m^2 and hungry gut phenotype.

    • 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.

    Exclusion Criteria:

    • 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.

    • Female subjects who are pregnant or breast-feeding.

    • 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.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Andres Acosta, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Andres J. Acosta, M.D., Ph.D., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05314374
    Other Study ID Numbers:
    • 21-008310
    • K23DK114460-04
    First Posted:
    Apr 6, 2022
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Andres J. Acosta, M.D., Ph.D., Principal Investigator, Mayo Clinic
    BMI of 30 or greater
    Additional relevant MeSH terms:
    Obesity
    Body Weight
    Bile Acids and Salts

    Study Results

    No Results Posted as of Jun 1, 2022