NCT06757608

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

1.4 years

First QC Date

December 26, 2024

Last Update Submit

December 26, 2024

Conditions

Keywords

Cardiovascular diseasesMetabolismMetabolomicsFishDietary protein

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 COMPARATOR

Tambaqui (Colossoma macropomum) meat intake, 7g per BMI unit

Other: Assessment of postprandial metabolism after intake of different meat

Sardine meat

ACTIVE COMPARATOR

Sardine (Opisthonema oglinum) meat intake, 7g per BMI unit

Other: Assessment of postprandial metabolism after intake of different meat

Beef

ACTIVE COMPARATOR

Beef (Bos taurus) meat intake, 7g per BMI unit

Other: Assessment of postprandial metabolism after intake of different meat

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.

BeefSardine meatTambaqui meat

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Crossover Randomized Controlled Trial
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

Locations