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

Primary Purpose

Metabolic Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

sugar oral load

fat oral load

sugar and fat oral load

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring vascular endothelial function, systemic microvascular reactivity, dysglycemia, dyslipidemia

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

dysglycemia and dyslipidemia
overweight and obesity

Sites / Locations

National Institute of Cardiology, Ministry of Health, BrazilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

sugar oral load

fat oral load

sugar and fat oral loads

Arm Description

oral ingestion of a high carbohydrate meal

oral ingestion of a high fat meal

oral ingestion of a high carbohydrate and fat meal

Outcomes

Primary Outcome Measures

endothelial-dependent microvascular function

alterations in skin microvascular conductance using laser-based methods

Secondary Outcome Measures

Full Information

NCT ID

NCT03515460

First Posted

April 20, 2018

Last Updated

March 21, 2023

Sponsor

National Institute of Cardiology, Laranjeiras, Brazil

1. Study Identification

Unique Protocol Identification Number

NCT03515460

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 10, 2018 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Institute of Cardiology, Laranjeiras, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

vascular endothelial function, systemic microvascular reactivity, dysglycemia, dyslipidemia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sugar oral load

Arm Type

Experimental

Arm Description

oral ingestion of a high carbohydrate meal

Arm Title

fat oral load

Arm Type

Experimental

Arm Description

oral ingestion of a high fat meal

Arm Title

sugar and fat oral loads

Arm Type

Experimental

Arm Description

oral ingestion of a high carbohydrate and fat meal

Intervention Type

Other

Intervention Name(s)

sugar oral load

Other Intervention Name(s)

dietary intervention

Intervention Description

The individuals will receive a sugar oral load (high sugar meal)

Intervention Type

Other

Intervention Name(s)

fat oral load

Other Intervention Name(s)

dietary intervention

Intervention Description

The individuals will a receive fat oral load (high fat meal)

Intervention Type

Other

Intervention Name(s)

sugar and fat oral load

Other Intervention Name(s)

dietary intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

endothelial-dependent microvascular function

Description

alterations in skin microvascular conductance using laser-based methods

Time Frame

one day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eduardo TIBIRICA, MD, Phd

Phone

+55-21-99914-6075

etibi@uol.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea Lorenzo, MD, PhD

Phone

+55-21-99531-6994

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

EDUARDO TIBIRICA, MD, PhD

Organizational Affiliation

National Institute of Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institute of Cardiology, Ministry of Health, Brazil

City

Rio de Janeiro

ZIP/Postal Code

22240-006

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eduardo V Tibirica, MD, PhD

Phone

+55-21-999146075

etibi@uol.com.br

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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