Fructose Rich Diet and Endothelial Function

Metabolic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939130
• Other study ID #: 84642318.8.0000.5347
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 23, 2018

Study information

• Verified date: May 2019
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 23, 2018
• Est. primary completion date: December 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aerobic Exercise
• Fructose Intolerance
• Fructose Metabolism Disorder
• Fructose Rich Diet
• Metabolic Disease
• Metabolic Diseases

Intervention

Dietary Supplement:
• Fructose
Consumption of 1.0g / kg of body mass / day of fructose.
• Glucose
Consumption of 1.0g / kg of body mass / day of glucose.

Other:
• Fructose and exercise
Consumption of 1.0g / kg of body mass / day of fructose + 3 weekly sessions of 60 minutes of aerobic exercise.

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow Mediated Dilatation		4 weeks
Primary	Concentration of Uric Acid		4 weeks
Primary	Concentration of Nitrite / Nitrate		4 weeks
Secondary	Concentration of Superoxide Dismutase Enzyme		4 weeks
Secondary	Concentration of Substances Reactive to Thiobarbituric Acid	Oxidative stress outcome	4 weeks
Secondary	Concentration of Total Cholesterol		4 weeks
Secondary	Concentration of Triglycerides		4 weeks
Secondary	Concentration of Low-Density Lipoprotein		4 weeks
Secondary	Concentration of High-Density Lipoprotein		4 weeks
Secondary	Concentration of Glucose		4 weeks
Secondary	Concentration of Insulin		4 weeks
Secondary	HOMA-IR		4 weeks
Secondary	HOMA-B		4 weeks
Secondary	Insulin Sensitivity	Oral glucose tolerance test	4 weeks
Secondary	Concentration of C-Reactive Protein		4 weeks
Secondary	Concentration of Endothelin-1		4 weeks
Secondary	24-hour Blood Pressure		4 weeks
Secondary	Heart Rate Variability		4 weeks
Secondary	Body Fat		4 weeks