Fructose Rich Diet and Endothelial Function

NCT03939130 | Completed

• 1 other identifier: 84642318.8.0000.5347
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Flow Mediated Dilatation

  4 weeks

• Concentration of Uric Acid

  4 weeks

• Concentration of Nitrite / Nitrate

  4 weeks

Secondary Outcomes (16)

• Concentration of Superoxide Dismutase Enzyme

  4 weeks

• Concentration of Substances Reactive to Thiobarbituric Acid

  4 weeks

• Concentration of Total Cholesterol

  4 weeks

• Concentration of Triglycerides

  4 weeks

• Concentration of Low-Density Lipoprotein

  4 weeks

Study Arms (3)

Fructose-rich diet

EXPERIMENTAL

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

Glucose-rich diet

ACTIVE COMPARATOR

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

Fructose-rich diet and exercise

EXPERIMENTAL

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

Interventions

Fructose DIETARY_SUPPLEMENT

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

Fructose-rich diet

Glucose DIETARY_SUPPLEMENT

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

Glucose-rich diet

Fructose and exercise OTHER

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

Fructose-rich diet and exercise

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Fructose; Glucose; Exercise

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 6, 2019
• Study Start: June 1, 2018
• Primary Completion: December 23, 2018
• Study Completion: December 23, 2018
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)