Fructose Rich Diet and Endothelial Function

Effects of Fructose Rich Diet Associated With Aerobic Training on Uric Acid Levels and Endothelial Function

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%.

Study Overview

• Status: Completed
• Conditions: Metabolic Disease; Aerobic Exercise; Fructose Metabolism Disorder; Fructose Rich Diet
• Intervention / Treatment: Dietary supplement: Fructose; Dietary supplement: Glucose; Other: Fructose and exercise

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Universidade Federal do Rio Grande do Sul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fructose-rich diet; 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.	Dietary supplement: Fructose; Consumption of 1.0g / kg of body mass / day of fructose.
ACTIVE_COMPARATOR: Glucose-rich diet; 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.	Dietary supplement: Glucose; Consumption of 1.0g / kg of body mass / day of glucose.
EXPERIMENTAL: Fructose-rich diet and exercise; 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.	Other: Fructose and exercise; Consumption of 1.0g / kg of body mass / day of fructose + 3 weekly sessions of 60 minutes of aerobic exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Flow Mediated Dilatation	4 weeks
Concentration of Uric Acid	4 weeks
Concentration of Nitrite / Nitrate	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Superoxide Dismutase Enzyme		4 weeks
Concentration of Substances Reactive to Thiobarbituric Acid	Oxidative stress outcome	4 weeks
Concentration of Total Cholesterol		4 weeks
Concentration of Triglycerides		4 weeks
Concentration of Low-Density Lipoprotein		4 weeks
Concentration of High-Density Lipoprotein		4 weeks
Concentration of Glucose		4 weeks
Concentration of Insulin		4 weeks
HOMA-IR		4 weeks
HOMA-B		4 weeks
Insulin Sensitivity	Oral glucose tolerance test	4 weeks
Concentration of C-Reactive Protein		4 weeks
Concentration of Endothelin-1		4 weeks
24-hour Blood Pressure		4 weeks
Heart Rate Variability		4 weeks
Body Fat		4 weeks

Collaborators and Investigators

• Sponsor: Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): December 23, 2018
• Study Completion (ACTUAL): December 23, 2018

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (ACTUAL): May 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: 84642318.8.0000.5347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No