Healthy, Obesity
Conditions
Keywords
BMI of 30 or greater
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.
Interventions
DIETARY_SUPPLEMENTIleocolonic-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.
DRUGPlacebo
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucagon-Like Peptide-1 (GLP-1) | 90 days | The number of participants that provided a blood sample for GLP-1 (ug/ml) . |
| Peptide Trosin Tyrosine (PYY) Hormone | 90 days | The number of participants that provided a blood sample for PYY. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | Baseline, 12 weeks | Change in weight, measured in kilograms (kg), from baseline visit to 12 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 17 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
Baseline characteristics
| Characteristic | Placebo Group | Total | Bile Acid Supplement Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 35 Participants | 18 Participants |
| Age, Continuous | 49.4 years STANDARD_DEVIATION 9.8 | 48.8 years STANDARD_DEVIATION 9.7 | 48.2 years STANDARD_DEVIATION 9.7 |
| BMI (kg/m2) | 37.9 kg/m2 STANDARD_DEVIATION 5.3 | 36 kg/m2 STANDARD_DEVIATION 4.5 | 35.3 kg/m2 STANDARD_DEVIATION 4 |
| Height, m | 1.7 m STANDARD_DEVIATION 0.1 | 1.7 m STANDARD_DEVIATION 0.1 | 1.7 m STANDARD_DEVIATION 0.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 35 Participants | 18 Participants |
| Region of Enrollment United States | 17 participants | 35 participants | 18 participants |
| Sex: Female, Male Female | 13 Participants | 21 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 14 Participants | 10 Participants |
| Weight, kg | 108.1 kg STANDARD_DEVIATION 24.3 | 107 kg STANDARD_DEVIATION 22 | 106.7 kg STANDARD_DEVIATION 18.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 14 / 18 | 3 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 |
Outcome results
Primary
Glucagon-Like Peptide-1 (GLP-1)
The number of participants that provided a blood sample for GLP-1 (ug/ml) .
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bile Acid Supplement Group | Glucagon-Like Peptide-1 (GLP-1) | 18 Participants |
| Placebo Group | Glucagon-Like Peptide-1 (GLP-1) | 17 Participants |
Primary
Peptide Trosin Tyrosine (PYY) Hormone
The number of participants that provided a blood sample for PYY.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bile Acid Supplement Group | Peptide Trosin Tyrosine (PYY) Hormone | 18 Participants |
| Placebo Group | Peptide Trosin Tyrosine (PYY) Hormone | 17 Participants |
Secondary
Change in Weight
Change in weight, measured in kilograms (kg), from baseline visit to 12 weeks.
Time frame: Baseline, 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bile Acid Supplement Group | Change in Weight | -0.82 kg |
| Placebo Group | Change in Weight | 0.12 kg |