Characterization of Bile Acid Pathway in Obesity

NCT03341052 | Completed Results

• 2 other identifiers: 16-007060K23DK114460
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Change in 48h-fecal Bile Acid Excretion (μmol/L) Between Baseline and High Fat Diet

  Change in 48h-fecal bile acid excretion (μmol/L) between baseline and high fat diet

  Baseline to approximately day 7 of week 2

• Change in 48h-fecal Bile Acid Excretion (μmol/L) Between Baseline and Low Fat Diet

  Change in 48h-fecal bile acid excretion (μmol/L) between baseline and low fat diet

  Baseline to approximately day 7 of week 4

Study Arms (2)

Obese Participants

ACTIVE COMPARATOR

Participants will be on each diet for one week prior to collection of laboratory samples. Participants will be on their normal diet on weeks 1 and 3, on the high fat diet on week 2, and low fat diet on week 4.

Other: Normal Diet; Other: High Fat Diet; Other: Low Fat Diet

Normal Weight Participants

ACTIVE COMPARATOR

Participants will be on each diet for one week prior to collection of laboratory samples. Participants will be on their normal diet on weeks 1 and 3, on the high fat diet on week 2, and low fat diet on week 4.

Other: Normal Diet; Other: High Fat Diet; Other: Low Fat Diet

Interventions

Normal Diet OTHER

The normal diet will consist of the participants' normal eating habits, and will be tracked by a food log. The participants will be on their normal diet during week 1 and week 3.

Normal Weight Participants; Obese Participants

High Fat Diet OTHER

The high fat diet will consist of 2700 kcal, 100g total fat (33%), 300mg cholesterol, 350g carbohydrates (52%), and 100g protein (15%). The participants will be on this diet during week 2.

Normal Weight Participants; Obese Participants

Low Fat Diet OTHER

The low fat diet will consist of 1200 kcal, 26g fat (20%), 78mg cholesterol, 150g carbohydrates (50%), and 100g protein (30%). The participants will be on this diet during week 4.

Normal Weight Participants; Obese Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment
• BMI: 18.5-25 kg/m2
• Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment
• BMI: ≥ 30 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity

Interventions

Diet, High-Fat; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics

Results Point of Contact

• Title: Andres Acosta
• Organization: Mayo Clinic

acosta.andres@mayo.edu

15072666931

Study Officials

• Andres J Acosta Cardenas

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: November 14, 2017
• Study Start: November 14, 2017
• Primary Completion: October 9, 2021
• Study Completion: October 9, 2021
• Last Updated: April 27, 2023
• Results First Posted: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)