Clinical trial NCT03939130: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fructose Metabolism Disorder
Fructose Rich Diet
Metabolic Disease
Aerobic Exercise
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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%.


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.

Primary outcomes:
measure: Flow Mediated Dilatation
timeFrame: 4 weeks
measure: Concentration of Uric Acid
timeFrame: 4 weeks
measure: Concentration of Nitrite / Nitrate
timeFrame: 4 weeks
Secondary outcomes:
measure: Concentration of Superoxide Dismutase Enzyme
timeFrame: 4 weeks
measure: Concentration of Substances Reactive to Thiobarbituric Acid
timeFrame: 4 weeks
measure: Concentration of Total Cholesterol
timeFrame: 4 weeks
measure: Concentration of Triglycerides
timeFrame: 4 weeks
measure: Concentration of Low-Density Lipoprotein
timeFrame: 4 weeks
measure: Concentration of High-Density Lipoprotein
timeFrame: 4 weeks
measure: Concentration of Glucose
timeFrame: 4 weeks
measure: Concentration of Insulin
timeFrame: 4 weeks
measure: HOMA-IR
timeFrame: 4 weeks
measure: HOMA-B
timeFrame: 4 weeks
measure: Insulin Sensitivity
timeFrame: 4 weeks
measure: Concentration of C-Reactive Protein
timeFrame: 4 weeks
measure: Concentration of Endothelin-1
timeFrame: 4 weeks
measure: 24-hour Blood Pressure
timeFrame: 4 weeks
measure: Heart Rate Variability
timeFrame: 4 weeks
measure: Body Fat
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
References: