Fructose Rich Diet and Endothelial Function

NCT ID: NCT03939130

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2018-12-23

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%.

Conditions

Fructose Metabolism Disorder; Fructose Rich Diet; Metabolic Disease; Aerobic Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fructose

Intervention Type: DIETARY_SUPPLEMENT

Consumption of 1.0g / kg of body mass / day of fructose.

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.

Group Type: ACTIVE_COMPARATOR

Glucose

Intervention Type: DIETARY_SUPPLEMENT

Consumption of 1.0g / kg of body mass / day of glucose.

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.

Group Type: EXPERIMENTAL

Fructose and exercise

Intervention Type: OTHER

Consumption of 1.0g / kg of body mass / day of fructose + 3 weekly sessions of 60 minutes of aerobic exercise.

Interventions

Fructose

Consumption of 1.0g / kg of body mass / day of fructose.

Intervention Type: DIETARY_SUPPLEMENT

Glucose

Consumption of 1.0g / kg of body mass / day of glucose.

Intervention Type: DIETARY_SUPPLEMENT

Fructose and exercise

Consumption of 1.0g / kg of body mass / day of fructose + 3 weekly sessions of 60 minutes of aerobic exercise.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Alvaro Reischak-Oliveira

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

84642318.8.0000.5347

Identifier Type: -

Identifier Source: org_study_id