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Active, Not Recruiting

NCT Number: NCT06758453

Bile Acids As Determinants of Postprandial Metabolism

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Health Bile Acid Synthesis Disorders Postprandial Lipids Metabolism Postprandial Metabolism

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of São Paulo

São Paulo, 05508+000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Challenge

Other

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

Primary outcomes

  1. Plasma markers of intermediate metabolism and inflammation

    Time frame: 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.

  2. Cytokines

    Time frame: 1 day

    IL-6 and TNF-α [pg/mL]

  3. Glucose levels

    Time frame: 1 day

    glucose levels [mg/dL]

  4. Lipid profile parameters

    Time frame: 1 day

    triglycerides, total cholesterol, and fractions [mg/dL].

  5. Bile Acids

    Time frame: 1 day

    bile acids [µmol/L]

Secondary outcomes

  1. Urine metabolome

    Time frame: 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

  2. 24-hour dietary

    Time frame: 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.

  3. Food Frequency Questionnaire (FFQ)

    Time frame: 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.

  4. Visual Analog Score (VAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Ministry of Education, Brazil

Registry information

Acronym: PRIME

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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