Postprandial Responses to Fish Intake
PREFish
1 other identifier
interventional
30
1 country
1
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2024
CompletedFirst Submitted
Initial submission to the registry
December 26, 2024
CompletedFirst Posted
Study publicly available on registry
January 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJanuary 3, 2025
December 1, 2024
1.4 years
December 26, 2024
December 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 weeks
Secondary Outcomes (1)
Urine metabolome
3 weeks
Study Arms (3)
Tambaqui meat
ACTIVE COMPARATORTambaqui (Colossoma macropomum) meat intake, 7g per BMI unit
Sardine meat
ACTIVE COMPARATORSardine (Opisthonema oglinum) meat intake, 7g per BMI unit
Beef
ACTIVE COMPARATORBeef (Bos taurus) meat intake, 7g per BMI unit
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy adults between 18 and 35 years and with a body mass index between 20 and 29 kg/m2.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- Fundação de Amparo à Pesquisa do Estado de São Paulocollaborator
- Ministry of Education, Brazilcollaborator
Study Sites (1)
University of São Paulo
São Paulo, São Paulo, 05508-000, Brazil
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor PhD
Study Record Dates
First Submitted
December 26, 2024
First Posted
January 3, 2025
Study Start
March 22, 2024
Primary Completion
September 1, 2025
Study Completion
December 1, 2025
Last Updated
January 3, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share