Bile Acid Synthesis Disorders, Health, Postprandial Lipids Metabolism, Postprandial Metabolism
Conditions
Keywords
Metabolism, Bile Acid, Metabolomics
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.
Interventions
OTHERDietary Challenge
Ingestion of a high-fat, high-glucose meal to induce postprandial variations in bile acids and other metabolic markers.
Sponsors
Ministry of Education, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bile Acids | 1 day | bile acids \[µmol/L\] |
| Plasma markers of intermediate metabolism and inflammation | 1 day | 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. |
| Cytokines | 1 day | IL-6 and TNF-α \[pg/mL\] |
| Glucose levels | 1 day | glucose levels \[mg/dL\] |
| Lipid profile parameters | 1 day | triglycerides, total cholesterol, and fractions \[mg/dL\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour dietary | 1 day | 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. |
| Food Frequency Questionnaire (FFQ) | 1 day | 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. |
| Visual Analog Score (VAS) | 1 day | The feeling of hunger and satiety will be assessed on a scale of 1 to 10 (arbitrary unit) every hour of the dietary challenge. |
| Urine metabolome | 1 day | 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 |
Countries
Brazil
Outcome results
None listed