Bile Acids As Determinants of Postprandial Metabolism (PRIME)

University of Sao Paulo

Status: Active, not recruiting

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

Treatments: Other: Dietary Challenge

Study type: Interventional

Funder types: Other

Identifiers

NCT06758453

73219523.1.0000.0067

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

General Population (First Phase)

Experimental group

Description:

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

Treatment:

Other: Dietary Challenge

High Responders (Second Phase)

Experimental group

Description:

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.

Treatment:

Other: Dietary Challenge