N/A
N=16
Characterization of Bile Acid Pathway in Obesity
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03341052 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Change in 48h-fecal Bile Acid Excretion (μmol/L) Between Baseline and High Fat Diet — 543; 344 (μmol/L)/48 hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Normal Diet (Other); High Fat Diet (Other); Low Fat Diet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 48h-fecal Bile Acid Excretion (μmol/L) Between Baseline and High Fat Diet |
543; 344 | — |
| PRIMARY Change in 48h-fecal Bile Acid Excretion (μmol/L) Between Baseline and Low Fat Diet |
717.6; 297 | — |
Summary
It is unknown whether the bile acid pathway is altered in obesity. This study is designed to compare obesity and health to determine if the bile acid pathway differs depending on health state.
Eligibility Criteria
Normal Weight Inclusion Criteria:
- Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment
- BMI: 18.5-25 kg/m2
Obese Inclusion Criteria:
- Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment
- BMI: ≥ 30 kg/m2
Exclusion Criteria for both Normal Weight and Obese Participants:
- History of abdominal surgery including cholecystectomy and other than appendectomy, Caesarian section or tubal ligation.
- Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, phentermine.
- Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), a self-administered alcoholism screening test (AUDIT-C) and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HAD score >11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. The AUDIT-C is a 3-item alcohol screening questionnaire that reliably identifies participants who are hazardous alcohol drinkers or have active alcohol use disorders. In men, a score of 4 or more is above the recommended limits will be reviewed by study personnel. In women, a score of 3 or more is above the recommended limits will be reviewed by study personnel. However when the points are above recommended limits, the provider will review the patient's alcohol intake over the past few months to confirm accuracy and determine study eligibility..
- Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, and thyroxin replacement therapy.
Data sourced from ClinicalTrials.gov (NCT03341052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.