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出境医 / 临床实验 / Fructose Rich Diet and Endothelial Function

Fructose Rich Diet and Endothelial Function

Study Description
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%.

Condition or disease Intervention/treatment Phase
Fructose Metabolism Disorder Fructose Rich Diet Metabolic Disease Aerobic Exercise Dietary Supplement: Fructose Dietary Supplement: Glucose Other: Fructose and exercise Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Fructose Rich Diet Associated With Aerobic Training on Uric Acid Levels and Endothelial Function
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : December 23, 2018
Actual Study Completion Date : December 23, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 Dietary Supplement: Fructose
Consumption of 1.0g / kg of body mass / day of fructose.
Active Comparator: 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.
 Dietary Supplement: Glucose
Consumption of 1.0g / kg of body mass / day of glucose.
Experimental: 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.
 Other: Fructose and exercise
Consumption of 1.0g / kg of body mass / day of fructose + 3 weekly sessions of 60 minutes of aerobic exercise.
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Locations
Layout table for location information
Brazil
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande Do Sul, Brazil
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE June 1, 2018
Actual Primary Completion Date December 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • Flow Mediated Dilatation [ Time Frame: 4 weeks ]
  • Concentration of Uric Acid [ Time Frame: 4 weeks ]
  • Concentration of Nitrite / Nitrate [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • Concentration of Superoxide Dismutase Enzyme [ Time Frame: 4 weeks ]
  • Concentration of Substances Reactive to Thiobarbituric Acid [ Time Frame: 4 weeks ]
    Oxidative stress outcome
  • Concentration of Total Cholesterol [ Time Frame: 4 weeks ]
  • Concentration of Triglycerides [ Time Frame: 4 weeks ]
  • Concentration of Low-Density Lipoprotein [ Time Frame: 4 weeks ]
  • Concentration of High-Density Lipoprotein [ Time Frame: 4 weeks ]
  • Concentration of Glucose [ Time Frame: 4 weeks ]
  • Concentration of Insulin [ Time Frame: 4 weeks ]
  • HOMA-IR [ Time Frame: 4 weeks ]
  • HOMA-B [ Time Frame: 4 weeks ]
  • Insulin Sensitivity [ Time Frame: 4 weeks ]
    Oral glucose tolerance test
  • Concentration of C-Reactive Protein [ Time Frame: 4 weeks ]
  • Concentration of Endothelin-1 [ Time Frame: 4 weeks ]
  • 24-hour Blood Pressure [ Time Frame: 4 weeks ]
  • Heart Rate Variability [ Time Frame: 4 weeks ]
  • Body Fat [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fructose Rich Diet and Endothelial Function
Official Title  ICMJE Effects of Fructose Rich Diet Associated With Aerobic Training on Uric Acid Levels and Endothelial Function
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%.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Fructose Metabolism Disorder
  • Fructose Rich Diet
  • Metabolic Disease
  • Aerobic Exercise
Intervention  ICMJE
  • Dietary Supplement: Fructose
    Consumption of 1.0g / kg of body mass / day of fructose.
  • Dietary Supplement: 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Dietary Supplement: Fructose
  • Active Comparator: 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.
    Intervention: Dietary Supplement: Glucose
  • Experimental: 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.
    Intervention: Other: Fructose and exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2019) 		21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 23, 2018
Actual Primary Completion Date December 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03939130
Other Study ID Numbers  ICMJE 84642318.8.0000.5347
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul
Study Sponsor  ICMJE Federal University of Rio Grande do Sul
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federal University of Rio Grande do Sul
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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