Bile Acids As Determinants of Postprandial Metabolism

NCT06758453 | Active Not Recruiting

• 1 other identifier: 73219523.1.0000.0067
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Health; Bile Acid Synthesis Disorders; Postprandial Metabolism; Postprandial Lipids Metabolism

Keywords

Metabolism; Bile Acid; Metabolomics

Outcome Measures

Primary Outcomes (5)

• Plasma markers of intermediate metabolism and inflammation

  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.

  1 day

• Cytokines

  IL-6 and TNF-α \[pg/mL\]

  1 day

• Glucose levels

  glucose levels \[mg/dL\]

  1 day

• Lipid profile parameters

  triglycerides, total cholesterol, and fractions \[mg/dL\].

  1 day

• Bile Acids

  bile acids \[µmol/L\]

  1 day

Secondary Outcomes (4)

• Urine metabolome

  1 day

• 24-hour dietary

  1 day

• Food Frequency Questionnaire (FFQ)

  1 day

• Visual Analog Score (VAS)

  1 day

Study Arms (2)

General Population (First Phase)

EXPERIMENTAL

150 healthy women will participate in the initial assessment of postprandial variability in bile acid (BA) levels after ingesting a test meal.

Other: Dietary Challenge

High Responders (Second Phase)

EXPERIMENTAL

A subgroup of 20 women with the highest postprandial increase in BA levels from the first phase will undergo further evaluation. A subgroup of 20 women with the lowest postprandial increase in BA levels from the first phase will undergo further evaluation.

Other: Dietary Challenge

Interventions

Dietary Challenge OTHER

Ingestion of a high-fat, high-glucose meal to induce postprandial variations in bile acids and other metabolic markers.

General Population (First Phase); High Responders (Second Phase)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: cisgender woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Ministry of Education, Brazil: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05508+000, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor PhD

Model Details: The project aims to map the variability in the appearance of bile acids (BAs) in systemic circulation and explore their role in regulating inflammation and metabolism after meal ingestion. To achieve this, postprandial changes in plasma BA concentrations will be measured in 100 healthy women using a simplified dietary challenge. Capillary blood samples (500 µL) will be collected at 7 time points over 5 hours following the consumption of a high-fat and high-glycemic meal. In the second phase, participants with the highest (n=20) and lowest (n=20) postprandial increases in circulating BAs will be invited for another dietary challenge with the same test meal. During this phase, venous blood samples will be collected to analyze clinical biochemistry markers, the plasma metabolome, signaling molecules (hormones and inflam

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 3, 2025
• Study Start: March 5, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)