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Completed

NCT Number: NCT03939130

Fructose Rich Diet 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%.

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Key information

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fructose

Dietary Supplement

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

Glucose

Dietary Supplement

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

Fructose and exercise

Other

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

Primary outcomes

  1. Flow Mediated Dilatation

    Time frame: 4 weeks

  2. Concentration of Uric Acid

    Time frame: 4 weeks

  3. Concentration of Nitrite / Nitrate

    Time frame: 4 weeks

Secondary outcomes

  1. Concentration of Superoxide Dismutase Enzyme

    Time frame: 4 weeks

  2. Concentration of Substances Reactive to Thiobarbituric Acid

    Time frame: 4 weeks

    Oxidative stress outcome

  3. Concentration of Total Cholesterol

    Time frame: 4 weeks

  4. Concentration of Triglycerides

    Time frame: 4 weeks

  5. Concentration of Low-Density Lipoprotein

    Time frame: 4 weeks

  6. Concentration of High-Density Lipoprotein

    Time frame: 4 weeks

  7. Concentration of Glucose

    Time frame: 4 weeks

  8. Concentration of Insulin

    Time frame: 4 weeks

  9. HOMA-IR

    Time frame: 4 weeks

  10. HOMA-B

    Time frame: 4 weeks

  11. Insulin Sensitivity

    Time frame: 4 weeks

    Oral glucose tolerance test

  12. Concentration of C-Reactive Protein

    Time frame: 4 weeks

  13. Concentration of Endothelin-1

    Time frame: 4 weeks

  14. 24-hour Blood Pressure

    Time frame: 4 weeks

  15. Heart Rate Variability

    Time frame: 4 weeks

  16. Body Fat

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 6, 2019
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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