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

Sponsor
National Institute of Cardiology, Laranjeiras, Brazil (Other)
Overall Status
Recruiting
CT.gov ID
NCT03515460
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
47.7
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: sugar oral load
  • Other: fat oral load
  • Other: sugar and fat oral load
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official 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.
Actual Study Start Date :
Dec 10, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: sugar oral load

oral ingestion of a high carbohydrate meal

Other: sugar oral load
The individuals will receive a sugar oral load (high sugar meal)
Other Names:
  • dietary intervention

    		•
    Experimental: fat oral load

    oral ingestion of a high fat meal

    Other: fat oral load
    The individuals will a receive fat oral load (high fat meal)
    Other Names:
  • dietary intervention

    		•
    Experimental: sugar and fat oral loads

    oral ingestion of a high carbohydrate and fat meal

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. endothelial-dependent microvascular function [one day]

      alterations in skin microvascular conductance using laser-based methods

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • healthy individuals presenting body mass index between 18.5 e 24.9 kg/m2
    Exclusion Criteria:

    • dysglycemia and dyslipidemia

    • overweight and obesity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institute of Cardiology, Ministry of Health, Brazil Rio de Janeiro Brazil 22240-006

    Sponsors and Collaborators

    • National Institute of Cardiology, Laranjeiras, Brazil

    Investigators

    • Principal Investigator: EDUARDO TIBIRICA, MD, PhD, National Institute of Cardiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eduardo Tibirica, MD, PhD, Senior Researcher, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
    ClinicalTrials.gov Identifier:
    NCT03515460
    Other Study ID Numbers:
    • CAAE 86854318.8.0000.5272
    First Posted:
    May 3, 2018
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eduardo Tibirica, MD, PhD, Senior Researcher, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
    vascular endothelial function
    systemic microvascular reactivity
    dysglycemia
    dyslipidemia
    Additional relevant MeSH terms:
    Metabolic Syndrome

    Study Results

    No Results Posted as of Jun 8, 2022