An interventional study of Dietary Challenge in Health, Bile Acid Synthesis Disorders and Postprandial Metabolism, sponsored by University of Sao Paulo. Active, not recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Basic science
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.
University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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.
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.
Time frame: 1 day
Cytokines
IL-6 and TNF-α \[pg/mL\]
Time frame: 1 day
Glucose levels
glucose levels \[mg/dL\]
Time frame: 1 day
Lipid profile parameters
triglycerides, total cholesterol, and fractions \[mg/dL\].
Time frame: 1 day
Bile Acids
bile acids \[µmol/L\]
Time frame: 1 day
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day
Plan to share: No
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This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo