Acute Effects of Oral Carbohydrate and Fat Loads on Systemic Microvascular Endothelial Function in Healthy Individuals.

NCT ID: NCT03515460

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2023-12-20

Brief Summary

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The present study was designed to evaluate vascular endothelial dysfunction resulting from the oral ingestion of high loads of sugar and fat meals in healthy individuals.

Detailed Description

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The chronic and elevated consumption of fat and carbohydrates is associated with the initiation and the progression of cardiovascular and metabolic diseases, including diabetes, obesity and metabolic syndrome. In general, chronic diseases are related to underlying modifiable cardiovascular risk factors, including high blood pressure, high plasma lipids and glucose, physical inactivity, overweight and obesity, as well as smoking habits.

Vascular endothelial dysfunction is one of the earliest findings in the pathophysiology of atherosclerosis and also an important predictor of cardiovascular events. Moreover, it has already been demonstrated that acute oral ingestion of high loads of sugar and fat meals induces transient vascular endothelial dysfunction, which over time could lead to cardiovascular disease.

Thus, the present study aimed at investigating the individual contributions of sugar and fat ingestion on systemic microvascular endothelial reactivity.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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sugar oral load

oral ingestion of a high carbohydrate meal

Group Type EXPERIMENTAL

sugar oral load

Intervention Type OTHER

The individuals will receive a sugar oral load (high sugar meal)

fat oral load

oral ingestion of a high fat meal

Group Type EXPERIMENTAL

fat oral load

Intervention Type OTHER

The individuals will a receive fat oral load (high fat meal)

sugar and fat oral loads

oral ingestion of a high carbohydrate and fat meal

Group Type EXPERIMENTAL

sugar and fat oral load

Intervention Type OTHER

The individuals will a receive sugar and fat oral load (high sugar and high fat meal)

Interventions

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sugar oral load

The individuals will receive a sugar oral load (high sugar meal)

Intervention Type OTHER

fat oral load

The individuals will a receive fat oral load (high fat meal)

Intervention Type OTHER

sugar and fat oral load

The individuals will a receive sugar and fat oral load (high sugar and high fat meal)

Intervention Type OTHER

Other Intervention Names

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dietary intervention dietary intervention dietary intervention

Eligibility Criteria

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Inclusion Criteria

* healthy individuals presenting body mass index between 18.5 e 24.9 kg/m2

Exclusion Criteria

* dysglycemia and dyslipidemia
* overweight and obesity
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eduardo Tibirica, MD, PhD

Senior Researcher, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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EDUARDO TIBIRICA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology

Locations

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National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CAAE 86854318.8.0000.5272

Identifier Type: -

Identifier Source: org_study_id

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