Post-prandial Glycaemic ResponsePREFishNCT06757608
Postprandial Responses to Fish Intake
A study testing Assessment of postprandial metabolism after intake of different meat in people with Post-prandial Glycaemic Response and Postprandial Lipids Metabolism, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Fish consumption has been increasing in recent decades due to consumer interest in the positive health effects of regular food intake, among other factors. Previous studies have described significant results on the acute consumption of fish products, favoring the reduction of triglycerides, total cholesterol… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-prandial Glycaemic Response, Postprandial Lipids Metabolism, Postprandial Metabolism
- What is being tested?
- Assessment of postprandial metabolism after intake of different meat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 22 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults between 18 and 35 years and with a body mass index between 20 and 29 kg/m2.
Who cannot join
- Individuals with a vegetarian/vegan diet, a history of fish allergy, aversion to fish, used supplementation with n-3 polyunsaturated fatty acids or probiotics, who have a diagnosis of pregnancy, dyslipidemia, diabetes, inflammatory bowel disease, liver disease, who have undergone surgeries that alter the anatomy of the digestive tract (bariatric surgery or cholecystectomy, for example) and use of antimicrobial therapy in the 3 months before the study will not be allowed to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postprandial Responses to Fish Intake: in Vivo and in Vitro Study
Fish consumption has been increasing in recent decades due to consumer interest in the positive health effects of regular food intake, among other factors. Previous studies have described significant results on the acute consumption of fish products, favoring the reduction of triglycerides, total cholesterol, low-density lipoprotein, reduced insulin secretion, and increased plasma concentration of high-density lipoprotein during the postprandial period. Despite this scenario, studies investigating acute metabolic responses, such as postprandial physiological phenomena after consumption of the main fish species ingested by Brazilians, are still scarce. Thus, investigations of the acute effects of fish intake on postprandial metabolism may reveal new beneficial effects associated with this food group. The present proposal aims to compare the acute effects of the ingestion of two sources of fish and bovine protein on postprandial metabolism through the capillary blood sample collected within 5 hours after the ingestion of test meals, investigating hormones and inflammatory mediators and quantifying triglycerides, total cholesterol and non-esterified fatty acids and blood glucose, in addition to evaluating sensory aspects and satiety between different meals. It is expected to generate new data on postprandial physiology and investigate possible effects of fish ingestion that can contribute to public health management and healthy eating patterns.
- Being tested
- Assessment of postprandial metabolism after intake of different meat
- Keywords
- Cardiovascular diseases, Metabolism, Metabolomics, Fish, Dietary protein
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of postprandial metabolism after intake of different meatOther
30 healthy adults (15 male and 15 female) consumed sardines (Opisthonema oglinum, marine fish), tambaqui (Colossoma macropomum, freshwater culture), and beef (Bos taurus). The meal consisted only of meat, with 7g per BMI unit. The postprandial response was observed for 5 hours, after an overnight fast.
| Study group | Role | What they receive |
|---|---|---|
| Tambaqui meat | Active comparator | Tambaqui (Colossoma macropomum) meat intake, 7g per BMI unit Receives: Other: Assessment of postprandial metabolism after intake of different meat |
| Sardine meat | Active comparator | Sardine (Opisthonema oglinum) meat intake, 7g per BMI unit Receives: Other: Assessment of postprandial metabolism after intake of different meat |
| Beef | Active comparator | Beef (Bos taurus) meat intake, 7g per BMI unit Receives: Other: Assessment of postprandial metabolism after intake of different meat |
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 500 µL) were collected after a 12-hour fasting and in different time points within a 5-hours interval after food intake to assess plasma metabolic and inflammatory markers (cytokines), aiming at identifying their response to the food intake.
Measured: 3 weeks
Secondary outcomes (1)
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: 3 weeks
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 start22 Mar 2024
- Primary completionSep 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 Post-prandial Glycaemic ResponseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Ministry of Education, Brazil
- Responsible party
- Principal investigator, Jarlei Fiamoncini, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757608
- Sponsor's protocol ID
- 69418723.6.0000.0067
- Acronym
- PREFish
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 3 Jan 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Responses to Fish Intake: in Vivo and in Vitro Study
- ClinicalTrials.gov ID
- NCT06757608
- Acronym / sponsor ID
- PREFish / 69418723.6.0000.0067
- Keywords
- Cardiovascular diseases, Metabolism, Metabolomics, Fish, Dietary protein
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Ministry of Education, Brazil
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- Sep 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.
Fish consumption has been increasing in recent decades due to consumer interest in the positive health effects of regular food intake, among other factors. Previous studies have described significant results on the acute consumption of fish products, favoring the reduction of triglycerides, total cholesterol, low-density lipoprotein, reduced insulin secretion, and increased plasma concentration of high-density lipoprotein during the postprandial period. Despite this scenario, studies investigating acute metabolic responses, such as postprandial physiological phenomena after consumption of the main fish species ingested by Brazilians, are still scarce. Thus, investigations of the acute effects of fish intake on postprandial metabolism may reveal new beneficial effects associated with this food group. The present proposal aims to compare the acute effects of the ingestion of two sources of fish and bovine protein on postprandial metabolism through the capillary blood sample collected within 5 hours after the ingestion of test meals, investigating hormones and inflammatory mediators and quantifying triglycerides, total cholesterol and non-esterified fatty acids and blood glucose, in addition to evaluating sensory aspects and satiety between different meals. It is expected to generate new data on postprandial physiology and investigate possible effects of fish ingestion that can contribute to public health management and healthy eating patterns.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Crossover Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Tambaqui meat | Active comparator | Other: Assessment of postprandial metabolism after intake of different meatTambaqui (Colossoma macropomum) meat intake, 7g per BMI unit |
| Sardine meat | Active comparator | Other: Assessment of postprandial metabolism after intake of different meatSardine (Opisthonema oglinum) meat intake, 7g per BMI unit |
| Beef | Active comparator | Other: Assessment of postprandial metabolism after intake of different meatBeef (Bos taurus) meat intake, 7g per BMI unit |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults between 18 and 35 years and with a body mass index between 20 and 29 kg/m2.
Key exclusion criteria (1 listed)
- Individuals with a vegetarian/vegan diet, a history of fish allergy, aversion to fish, used supplementation with n-3 polyunsaturated fatty acids or probiotics, who have a diagnosis of pregnancy, dyslipidemia, diabetes, inflammatory bowel disease, liver disease, who have undergone surgeries that alter the anatomy of the digestive tract (bariatric surgery or cholecystectomy, for example) and use of antimicrobial therapy in the 3 months before the study will not be allowed to participate.
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 |
|---|---|---|
| Assessment of postprandial metabolism after intake of different meat30 healthy adults (15 male and 15 female) consumed sardines (Opisthonema oglinum, marine fish), tambaqui (Colossoma macropomum, freshwater culture), and beef (Bos taurus). The meal consisted only of meat, with 7g per BMI unit. The postprandial response was observed for 5 hours, after an overnight fast. | Other | Beef, Sardine meat, Tambaqui meat |
Primary outcome
Plasma markers of intermediate metabolism and inflammation
Time frame: 3 weeks
Capillary blood samples (approximately 500 µL) were collected after a 12-hour fasting and in different time points within a 5-hours interval after food intake to assess plasma metabolic and inflammatory markers (cytokines), aiming at identifying their response to the food intake.
1 secondary outcome
Urine metabolome
Time frame: 3 weeks
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 3 Jan 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 Assessment of postprandial metabolism after intake of different meat in people with Post-prandial Glycaemic Response and Postprandial Lipids Metabolism, 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 1 inclusion and 1 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 3 Jan 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: 3 weeks). 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 3 Jan 2025.