Clinical trial NCT06757608: Postprandial Responses to Fish Intake
Official title: Postprandial Responses to Fish Intake: in Vivo and in Vitro Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-prandial Glycaemic Response
Postprandial Lipids Metabolism
Postprandial Metabolism
Keywords: Cardiovascular diseases
Metabolism
Metabolomics
Fish
Dietary protein
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: CAPES Foundation - Ministry of Education, Brazil.
First posted: 2025-01-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Randomized Controlled Trial
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* Healthy adults between 18 and 35 years and with a body mass index between 20 and 29 kg/m2.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Plasma markers of intermediate metabolism and inflammation
timeFrame: 3 weeks
Secondary outcomes:
measure: Urine metabolome
timeFrame: 3 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
References: