NCT03515460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

December 10, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

5 years

First QC Date

April 20, 2018

Last Update Submit

March 24, 2024

Conditions

Metabolic Syndrome

Keywords

vascular endothelial functionsystemic microvascular reactivitydysglycemiadyslipidemia

Outcome Measures

Primary Outcomes (1)

  • endothelial-dependent microvascular function

    alterations in skin microvascular conductance using laser-based methods

    one day

Study Arms (3)

sugar oral load

EXPERIMENTAL

oral ingestion of a high carbohydrate meal

Other: sugar oral load

fat oral load

EXPERIMENTAL

oral ingestion of a high fat meal

Other: fat oral load

sugar and fat oral loads

EXPERIMENTAL

oral ingestion of a high carbohydrate and fat meal

Other: sugar and fat oral load

Interventions

sugar oral loadOTHER

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

Also known as: dietary intervention
sugar oral load
fat oral loadOTHER

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

Also known as: dietary intervention
fat oral load
sugar and fat oral loadOTHER

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

Also known as: dietary intervention
sugar and fat oral loads

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • dysglycemia and dyslipidemia
  • overweight and obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, 22240-006, Brazil

Location

MeSH Terms

Conditions

Metabolic SyndromeDyslipidemias

Interventions

Diet TherapySugars

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeuticsCarbohydrates

Study Officials

  • EDUARDO TIBIRICA, MD, PhD

    National Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher, MD, PhD

Study Record Dates

First Submitted

April 20, 2018

First Posted

May 3, 2018

Study Start

December 10, 2018

Primary Completion

December 1, 2023

Study Completion

December 20, 2023

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations

BR(1)