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

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ClinicalTrials.gov Identifier: NCT03515460
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Eduardo Tibirica, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: sugar oral load Other: fat oral load Other: sugar and fat oral load Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 10, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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 Name: 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 Name: 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 Name: dietary intervention




Primary Outcome Measures :
  1. endothelial-dependent microvascular function [ Time Frame: one day ]
    alterations in skin microvascular conductance using laser-based methods



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • dysglycemia and dyslipidemia
  • overweight and obesity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515460


Contacts
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Contact: Eduardo TIBIRICA, MD, Phd +55-21-99914-6075 etibi@uol.com.br
Contact: Andrea Lorenzo, MD, PhD +55-21-99531-6994

Locations
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Brazil
National Institute of Cardiology, Ministry of Health, Brazil Recruiting
Rio de Janeiro, Brazil, 22240-006
Contact: Eduardo V Tibirica, MD, PhD    +55-21-999146075    etibi@uol.com.br   
Sponsors and Collaborators
National Institute of Cardiology, Laranjeiras, Brazil
Investigators
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Principal Investigator: EDUARDO TIBIRICA, MD, PhD National Institute of Cardiology

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Responsible Party: Eduardo Tibirica, MD, PhD, Senior Researcher, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier: NCT03515460     History of Changes
Other Study ID Numbers: CAAE 86854318.8.0000.5272
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, National Institute of Cardiology, Laranjeiras, Brazil:
vascular endothelial function
systemic microvascular reactivity
dysglycemia
dyslipidemia

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases