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Fructose Rich Diet and Endothelial Function

Primary Purpose

Fructose Metabolism Disorder, Fructose Rich Diet, Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Fructose
Glucose
Fructose and exercise
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fructose Metabolism Disorder

Eligibility Criteria

19 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and women;
  • Not engaged in regular exercises;
  • Aged between 19 and 35 years;
  • Body mass index (BMI) of less than 30kg / m².

Exclusion Criteria:

  • Individuals with BMI below 18kg / m² and greater than 30kg / m²;
  • Smokers;
  • Dyslipidemic;
  • Diabetic;
  • Hypertensive;
  • Alcohol use;
  • Appetite suppressants use;
  • Medications use;
  • Supplements use;
  • Chronic disease that impedes the performance of physical exercise.

Sites / Locations

  • Universidade Federal do Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Fructose-rich diet

Glucose-rich diet

Fructose-rich diet and exercise

Arm Description

Subjects will be submitted to a standard diet associated with a sweetened beverage (provided by the researchers) during 4 weeks. Without knowing the content (blind), they will receive fructose based beverage, prepared as a solution with 10% fructose, water and flavoring powder, totaling 1.0g / kg of body mass / day of fructose.

Subjects will be submitted to a standard diet associated with a sweetened beverage (provided by the researchers) during 4 weeks. Without knowing the content (blind), they will receive glucose based beverage, prepared as a solution with 10% glucose, water and flavoring powder, totaling 1.0g / kg of body mass / day of glucose.

The subjects will perform the same protocol described in the intervention Fructose-rich diet, except for the inclusion of the physical exercise. During the 4-week intervention, participants will perform three sessions a week of 60 minutes of aerobic exercise at 60% of VO2 peak on cycle ergometer.

Outcomes

Primary Outcome Measures

Flow Mediated Dilatation
Concentration of Uric Acid
Concentration of Nitrite / Nitrate

Secondary Outcome Measures

Concentration of Superoxide Dismutase Enzyme
Concentration of Substances Reactive to Thiobarbituric Acid
Oxidative stress outcome
Concentration of Total Cholesterol
Concentration of Triglycerides
Concentration of Low-Density Lipoprotein
Concentration of High-Density Lipoprotein
Concentration of Glucose
Concentration of Insulin
HOMA-IR
HOMA-B
Insulin Sensitivity
Oral glucose tolerance test
Concentration of C-Reactive Protein
Concentration of Endothelin-1
24-hour Blood Pressure
Heart Rate Variability
Body Fat

Full Information

First Posted
April 29, 2019
Last Updated
May 2, 2019
Sponsor
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03939130
Brief Title
Fructose Rich Diet and Endothelial Function
Official Title
Effects of Fructose Rich Diet Associated With Aerobic Training on Uric Acid Levels and Endothelial Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 23, 2018 (Actual)
Study Completion Date
December 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Cardiometabolic diseases have been associated with high consumption of sweetened beverages. These products are responsible for the largest portion of the total consumption of fructose in the diet and it is suggested that excessive intake of this monosaccharide may contribute to the development of risk factors for these diseases due to differences in metabolism relative to glucose. However, there is a lack of data in the literature demonstrating the deleterious effects of excessive fructose consumption on vasodilation and whether aerobic training may be able to prevent or mitigate these damages in humans. Therefore, the aim of the study will be to verify the effect of 4 weeks of high fructose diet associated with aerobic training on uric acid levels and its influence on markers related to oxidative stress and vasodilatation. Twenty-one sedentary men and women, aged between 19 and 35 years, will be submitted to 4 weeks of intervention. In a randomized way, subjects will be divided into 3 groups: high fructose diet, high glucose diet and high fructose diet and exercise. Blood samples will be taken before, in the middle and after the intervention to verify the concentrations of uric acid, superoxide dismutase enzyme, thiobarbituric acid, nitrite / nitrate, lipid profile, glucose, insulin, C-reactive protein and endothelin-1. In addition, flow-mediated dilatation, insulin resistance index, pancreatic beta cell functional capacity index, oral glucose tolerance test, 24-hour blood pressure, heart rate variability and body composition will be analyzed. The comparisons will be performed through the Generalized Estimates of Equations, adopting the factors group and time. The Bonferroni post-hoc will be used to identify differences. The accepted level of significance will be 5%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fructose Metabolism Disorder, Fructose Rich Diet, Metabolic Disease, Aerobic Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fructose-rich diet
Arm Type
Experimental
Arm Description
Subjects will be submitted to a standard diet associated with a sweetened beverage (provided by the researchers) during 4 weeks. Without knowing the content (blind), they will receive fructose based beverage, prepared as a solution with 10% fructose, water and flavoring powder, totaling 1.0g / kg of body mass / day of fructose.
Arm Title
Glucose-rich diet
Arm Type
Active Comparator
Arm Description
Subjects will be submitted to a standard diet associated with a sweetened beverage (provided by the researchers) during 4 weeks. Without knowing the content (blind), they will receive glucose based beverage, prepared as a solution with 10% glucose, water and flavoring powder, totaling 1.0g / kg of body mass / day of glucose.
Arm Title
Fructose-rich diet and exercise
Arm Type
Experimental
Arm Description
The subjects will perform the same protocol described in the intervention Fructose-rich diet, except for the inclusion of the physical exercise. During the 4-week intervention, participants will perform three sessions a week of 60 minutes of aerobic exercise at 60% of VO2 peak on cycle ergometer.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fructose
Intervention Description
Consumption of 1.0g / kg of body mass / day of fructose.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose
Intervention Description
Consumption of 1.0g / kg of body mass / day of glucose.
Intervention Type
Other
Intervention Name(s)
Fructose and exercise
Intervention Description
Consumption of 1.0g / kg of body mass / day of fructose + 3 weekly sessions of 60 minutes of aerobic exercise.
Primary Outcome Measure Information:
Title
Flow Mediated Dilatation
Time Frame
4 weeks
Title
Concentration of Uric Acid
Time Frame
4 weeks
Title
Concentration of Nitrite / Nitrate
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Concentration of Superoxide Dismutase Enzyme
Time Frame
4 weeks
Title
Concentration of Substances Reactive to Thiobarbituric Acid
Description
Oxidative stress outcome
Time Frame
4 weeks
Title
Concentration of Total Cholesterol
Time Frame
4 weeks
Title
Concentration of Triglycerides
Time Frame
4 weeks
Title
Concentration of Low-Density Lipoprotein
Time Frame
4 weeks
Title
Concentration of High-Density Lipoprotein
Time Frame
4 weeks
Title
Concentration of Glucose
Time Frame
4 weeks
Title
Concentration of Insulin
Time Frame
4 weeks
Title
HOMA-IR
Time Frame
4 weeks
Title
HOMA-B
Time Frame
4 weeks
Title
Insulin Sensitivity
Description
Oral glucose tolerance test
Time Frame
4 weeks
Title
Concentration of C-Reactive Protein
Time Frame
4 weeks
Title
Concentration of Endothelin-1
Time Frame
4 weeks
Title
24-hour Blood Pressure
Time Frame
4 weeks
Title
Heart Rate Variability
Time Frame
4 weeks
Title
Body Fat
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women; Not engaged in regular exercises; Aged between 19 and 35 years; Body mass index (BMI) of less than 30kg / m². Exclusion Criteria: Individuals with BMI below 18kg / m² and greater than 30kg / m²; Smokers; Dyslipidemic; Diabetic; Hypertensive; Alcohol use; Appetite suppressants use; Medications use; Supplements use; Chronic disease that impedes the performance of physical exercise.
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Fructose Rich Diet and Endothelial Function

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