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

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: sugar and fat oral load; Other: sugar oral load; Other: fat oral load

• Registration Number: NCT03515460
• Lead Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-04-20
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-03
• Study Start: 2018-12-10
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• dysglycemia and dyslipidemia
• overweight and obesity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar and fat oral loads	sugar and fat oral load	oral ingestion of a high carbohydrate and fat meal
sugar oral load	sugar oral load	oral ingestion of a high carbohydrate meal
fat oral load	fat oral load	oral ingestion of a high fat meal

Primary Outcome Measures

Name	Time	Method
endothelial-dependent microvascular function	one day	alterations in skin microvascular conductance using laser-based methods

Trial Locations

Locations (1)

National Institute of Cardiology, Ministry of Health, Brazil; 🇧🇷 Rio de Janeiro, Brazil