Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 68 of 228 for:    EDN1

Fructose Rich Diet and Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03939130
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Alvaro Reischak-Oliveira, Federal University of Rio Grande do Sul

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

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

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

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.




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939130


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

Layout table for additonal information
Responsible Party: Alvaro Reischak-Oliveira, Principal Investigator, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03939130     History of Changes
Other Study ID Numbers: 84642318.8.0000.5347
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Diseases