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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK114460 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bile Acid Supplement Group | Experimental | Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements |
|
| Placebo Group | Placebo Comparator | Subjects with obesity and abnormal satiety phenotype will receive matching-placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ileocolonic-release conjugated bile acid | Dietary Supplement | 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon-Like Peptide-1 (GLP-1) | The number of participants that provided a blood sample for GLP-1 (ug/ml) . | 90 days |
| Peptide Trosin Tyrosine (PYY) Hormone | The number of participants that provided a blood sample for PYY. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Change in weight, measured in kilograms (kg), from baseline visit to 12 weeks. | Baseline, 12 weeks |
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Inclusion criteria:
I. Patients with obesity BMI> 30 kg/m2 and hungry gut phenotype.
II. Age: 18-65 years.
III. 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.
IV. Otherwise healthy individuals or with controlled chronic medical conditions such as type 2 diabetes.
Exclusion criteria:
I. 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.
II. Subjects with stool type Bristol classification 6-7 per bowel disease questionnaire.
III. Female subjects who are pregnant or breast-feeding.
IV. Use of anti-obesity medications upon screening (ie., orlistat, phentermine-topiramate, liraglutide, semaglutide, bupropion-naltrexone), metformin or GLP-1 analogs.
V. Individuals who are currently on treatment for unstable cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine, and psychiatric disease.
VI. 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.
VII. 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.
VII. Principal Investigator discretion.
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| Name | Affiliation | Role |
|---|---|---|
| Andres Acosta, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bile Acid Supplement Group | Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements 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 |
| FG001 | Placebo Group | Subjects with obesity and abnormal satiety phenotype will receive matching-placebo 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bile Acid Supplement Group | Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements Ileocolonic-release conjugated bile acid: 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glucagon-Like Peptide-1 (GLP-1) | The number of participants that provided a blood sample for GLP-1 (ug/ml) . | Posted | Count of Participants | Participants | 90 days |
|
Adverse events were collected from the time of consent through completion of the study, approximately 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bile Acid Supplement Group | Subjects with obesity and abnormal satiety phenotype will receive ileocolonic-release conjugated bile acid supplements Ileocolonic-release conjugated bile acid: 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andres Acosta | Mayo Clinic | 507-266-6931 | acosta.andres@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2023 | Mar 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
|
| Placebo | Drug | Placebo looks exactly like the study drug, but it contains no active ingredient. 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study. |
|
|
| BG001 | Placebo Group | Subjects with obesity and abnormal satiety phenotype will receive matching-placebo Placebo: Placebo looks exactly like the study drug, but it contains no active ingredient. 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight, kg | Mean | Standard Deviation | kg |
|
| Height, m | Mean | Standard Deviation | m |
|
| BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
|
|
| Primary | Peptide Trosin Tyrosine (PYY) Hormone | The number of participants that provided a blood sample for PYY. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Change in Weight | Change in weight, measured in kilograms (kg), from baseline visit to 12 weeks. | Posted | Mean | 95% Confidence Interval | kg | Baseline, 12 weeks |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 14 |
| 18 |
| EG001 | Placebo Group | Subjects with obesity and abnormal satiety phenotype will receive matching-placebo Placebo: Placebo looks exactly like the study drug, but it contains no active ingredient. 500 mg tablets orally twice daily on an empty stomach, 30 minutes prior to breakfast and evening dinner for 90 +/- 5 days. Subjects will receive 500 mg twice daily during their first week and 1000 mg twice daily for the rest of the study. | 0 | 17 | 0 | 17 | 3 | 17 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |