Bile Acids As Determinants of Postprandial Metabolism (PRIME)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Health; Postprandial Metabolism; Bile Acid Synthesis Disorders; Postprandial Lipids Metabolism
• Intervention / Treatment: Other: Dietary Challenge

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05508+000
    • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: General Population (First Phase); 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; Ingestion of a high-fat, high-glucose meal to induce postprandial variations in bile acids and other metabolic markers.
Experimental: High Responders (Second Phase); 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; Ingestion of a high-fat, high-glucose meal to induce postprandial variations in bile acids and other metabolic markers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine metabolome	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	1 day
24-hour dietary	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.	1 day
Food Frequency Questionnaire (FFQ)	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.	1 day
Visual Analog Score (VAS)	The feeling of hunger and satiety will be assessed on a scale of 1 to 10 (arbitrary unit) every hour of the dietary challenge.	1 day

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; CAPES Foundation - Ministry of Education, Brazil.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: December 27, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Metabolomics; Metabolism; Bile Acid
• Other Study ID Numbers: 73219523.1.0000.0067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No