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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2023

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: sugar oral load
    • oral ingestion of a high carbohydrate meal
  • Experimental: fat oral load
    • oral ingestion of a high fat meal
  • Experimental: sugar and fat oral loads
    • oral ingestion of a high carbohydrate and fat meal

Clinical Trial Outcome Measures

Primary Measures

  • endothelial-dependent microvascular function
    • Time Frame: one day
    • alterations in skin microvascular conductance using laser-based methods

Participating in This Clinical Trial

Inclusion Criteria

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

  • dysglycemia and dyslipidemia – overweight and obesity

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Institute of Cardiology, Laranjeiras, Brazil
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eduardo Tibirica, MD, PhD, Senior Researcher, MD, PhD – National Institute of Cardiology, Laranjeiras, Brazil
  • Overall Official(s)
    • EDUARDO TIBIRICA, MD, PhD, Principal Investigator, National Institute of Cardiology

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