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Completed

NCT Number: NCT03515460

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

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.

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Key information

Conditions

Metabolic Syndrome Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, 22240-006, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • dysglycemia and dyslipidemia
  • overweight and obesity

Treatment and study plan

sugar oral load

Other

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

Other names: dietary intervention

fat oral load

Other

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

Other names: dietary intervention

sugar and fat oral load

Other

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

Other names: dietary intervention

Primary outcomes

  1. endothelial-dependent microvascular function

    Time frame: one day

    alterations in skin microvascular conductance using laser-based methods

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 3, 2018
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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