HealthPRIMENCT06758453
Bile Acids As Determinants of Postprandial Metabolism
A study testing Dietary Challenge in people with Health and Bile Acid Synthesis Disorders, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health, Bile Acid Synthesis Disorders, Postprandial Metabolism
- What is being tested?
- Dietary Challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Mar 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged between 18 and 70 years
- Body mass index (BMI) between 18.5 and 34.9 kg/m²
Who cannot join
- Pregnant women
- History of bariatric surgery and/or intestinal resection
- Inflammatory bowel disease
- Celiac disease
- Liver disease
- Type 2 diabetes mellitus
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Health, Bile Acid Synthesis Disorders, Postprandial Metabolism, Postprandial Lipids Metabolism
- Being tested
- Dietary Challenge
- Keywords
- Metabolism, Bile Acid, Metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary ChallengeOther
Ingestion of a high-fat, high-glucose meal to induce postprandial variations in bile acids and other metabolic markers.
| Study group | Role | What they receive |
|---|---|---|
| General Population (First Phase) | Experimental | 150 healthy women will participate in the initial assessment of postprandial variability in bile acid (BA) levels after ingesting a test meal. Receives: Other: Dietary Challenge |
| High Responders (Second Phase) | Experimental | 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. Receives: Other: Dietary Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Cytokines
IL-6 and TNF-α [pg/mL]
Measured: 1 day
Glucose levels
glucose levels [mg/dL]
Measured: 1 day
Lipid profile parameters
triglycerides, total cholesterol, and fractions [mg/dL].
Measured: 1 day
Bile Acids
bile acids [µmol/L]
Measured: 1 day
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start5 Mar 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Brazil, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Jarlei Fiamoncini, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758453
- Sponsor's protocol ID
- 73219523.1.0000.0067
- Acronym
- PRIME
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bile Acids As Determinants of Postprandial Metabolism
- ClinicalTrials.gov ID
- NCT06758453
- Acronym / sponsor ID
- PRIME / 73219523.1.0000.0067
- Conditions
- Health, Bile Acid Synthesis Disorders, Postprandial Metabolism, Postprandial Lipids Metabolism
- Keywords
- Metabolism, Bile Acid, Metabolomics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Ministry of Education, Brazil, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| General Population (First Phase) | Experimental | Other: Dietary Challenge150 healthy women will participate in the initial assessment of postprandial variability in bile acid (BA) levels after ingesting a test meal. |
| High Responders (Second Phase) | Experimental | Other: Dietary ChallengeA 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged between 18 and 70 years
- Body mass index (BMI) between 18.5 and 34.9 kg/m²
Key exclusion criteria (10 listed)
- Pregnant women
- History of bariatric surgery and/or intestinal resection
- Inflammatory bowel disease
- Celiac disease
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary ChallengeIngestion of a high-fat, high-glucose meal to induce postprandial variations in bile acids and other metabolic markers. | Other | General Population (First Phase), High Responders (Second Phase) |
Primary outcome
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.
Cytokines
Time frame: 1 day
IL-6 and TNF-α [pg/mL]
Glucose levels
Time frame: 1 day
glucose levels [mg/dL]
Lipid profile parameters
Time frame: 1 day
triglycerides, total cholesterol, and fractions [mg/dL].
Bile Acids
Time frame: 1 day
bile acids [µmol/L]
4 secondary outcomes
Urine metabolome
Time frame: 1 day
24-hour dietary
Time frame: 1 day
Food Frequency Questionnaire (FFQ)
Time frame: 1 day
Visual Analog Score (VAS)
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Challenge in people with Health and Bile Acid Synthesis Disorders, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma markers of intermediate metabolism and inflammation (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.