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NCT03515460 Clinical Trial

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

Metabolic Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03515460
Other study ID # CAAE 86854318.8.0000.5272
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 10, 2018
Est. completion date December 20, 2023

Study information
Verified date March 2024
Source National Institute of Cardiology, Laranjeiras, Brazil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 20, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Brazil National Institute of Cardiology, Ministry of Health, Brazil Rio de Janeiro

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary endothelial-dependent microvascular function alterations in skin microvascular conductance using laser-based methods one day
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