Bile Acids As Determinants of Postprandial Metabolism

Not Applicable

Active, not recruiting

• Conditions: Health; Bile Acid Synthesis Disorders; Postprandial Metabolism; Postprandial Lipids Metabolism

• Registration Number: NCT06758453
• Lead Sponsor: University of Sao Paulo

Brief Summary

This study aims to understand how bile acids (BAs) appear in the bloodstream after eating and how this might affect inflammation and metabolism. To do this, we will measure changes in BA levels in 100 healthy women after they eat a high-fat and high-carbohydrate meal. Blood samples (a small amount of 500 µL) will be collected from a finger prick at 7 time points over 5 hours. In the second part of the study, 40 women will be invited back-20 with the highest and 20 with the lowest increases in BAs. These participants will eat the same test meal, and blood samples will be taken from a vein to study markers of health, metabolism, inflammation, and the gut microbiome. By exploring how BAs work in the body, this study hopes to find new ways to understand and prevent chronic diseases.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-05
• Status Verified: 2024-12
• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2024-12-27
• Study First Posted: 2025-01-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Women aged between 18 and 70 years
• Body mass index (BMI) between 18.5 and 34.9 kg/m²

Exclusion Criteria

• Pregnant women
• History of bariatric surgery and/or intestinal resection
• Inflammatory bowel disease
• Celiac disease
• Liver disease
• Type 2 diabetes mellitus
• Casein allergy
• Alcohol consumption >30 g/day
• Use of antimicrobial therapy within the past two months

Note: The use of dietary supplements was not considered an exclusion factor. The use of medication for the treatment of chronic diseases was evaluated on a case-by-case basis and did not constitute, a priori, an exclusion factor.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Plasma markers of intermediate metabolism and inflammation	1 day	Capillary blood samples (approximately 200 µL) were collected after a 12-hour fasting period and at different time points within a 5-hour interval after food intake to assess plasma metabolic and inflammatory markers, such as cytokines (IL-6 and TNF-α \[pg/mL\]), glucose levels \[mg/dL\], lipid profile parameters, including triglycerides, total cholesterol, and fractions \[mg/dL\], as well as bile acids \[µmol/L\]. These measurements aim to identify the physiological and metabolic responses to food intake.
Cytokines	1 day	IL-6 and TNF-α \[pg/mL\]
Glucose levels	1 day	glucose levels \[mg/dL\]
Lipid profile parameters	1 day	triglycerides, total cholesterol, and fractions \[mg/dL\].
Bile Acids	1 day	bile acids \[µmol/L\]

Secondary Outcome Measures

Name	Time	Method
Urine metabolome	1 day	Urine samples were collected after a 12-hours fasting and during the postprandial period (all urine produced during the first 5 hours following food intake) to assess changes in urinary metabolome induced by the intake of the tested meal
24-hour dietary	1 day	To assess the participants' food consumption on the day before collection, we applied a 24-hour food recall in which the participant reported everything that was consumed.
Food Frequency Questionnaire (FFQ)	1 day	To assess the participants' eating patterns, we applied the quantitative Food Frequency Questionnaire (FFQ) that assesses the participant's food consumption over the last year.
Visual Analog Score (VAS)	1 day	The feeling of hunger and satiety will be assessed on a scale of 1 to 10 (arbitrary unit) every hour of the dietary challenge.

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 São Paulo, Brazil