Bile Acids As Determinants of Postprandial Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Health Bile Acid Synthesis Disorders Postprandial Metabolism Postprandial Lipids Metabolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dietary Challenge

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Dietary Challenge

Intervention Type OTHER

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

Interventions

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Dietary Challenge

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes