Clinical trial NCT06758453: Bile Acids As Determinants of Postprandial Metabolism
Official title: Bile Acids As Determinants of Postprandial Metabolism
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health
Bile Acid Synthesis Disorders
Postprandial Metabolism
Postprandial Lipids Metabolism
Keywords: Metabolism
Bile Acid
Metabolomics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: CAPES Foundation - Ministry of Education, Brazil.
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2025-01-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Plasma markers of intermediate metabolism and inflammation
timeFrame: 1 day
measure: Cytokines
timeFrame: 1 day
measure: Glucose levels
timeFrame: 1 day
measure: Lipid profile parameters
timeFrame: 1 day
measure: Bile Acids
timeFrame: 1 day
Secondary outcomes:
measure: Urine metabolome
timeFrame: 1 day
measure: 24-hour dietary
timeFrame: 1 day
measure: Food Frequency Questionnaire (FFQ)
timeFrame: 1 day
measure: Visual Analog Score (VAS)
timeFrame: 1 day
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
References: