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NCT03939130
Fructose Rich Diet and Endothelial Function
NA trial testing Fructose in Fructose Metabolism Disorder in 21 participants. Completed in 23 December 2018.
23 December 2018
Quick facts
| Lead sponsor | Federal University of Rio Grande do Sul |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 21 |
| Start date | 1 June 2018 |
| Primary completion | 23 December 2018 |
| Estimated completion | 23 December 2018 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
Conditions studied
- Fructose Metabolism Disorder — all drugs for Fructose Metabolism Disorder →
- Fructose Rich Diet — all drugs for Fructose Rich Diet →
- Metabolic Disease — all drugs for Metabolic Disease →
- Aerobic Exercise — all drugs for Aerobic Exercise →
Sponsor
Federal University of Rio Grande do Sul
Who can join
Adults 19 to 35, any sex, with Fructose Metabolism Disorder or Fructose Rich Diet. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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%.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03939130
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other trials of Fructose
Trials testing the same drug.
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- NCT03067428 — Effects of Fructose Restriction on Liver Steatosis · NA · completed
- NCT03247114 — fMRI of Hypothalamic Responses to Glucose, Fructose, Sucrose and Sucralose · NA · completed
- NCT03157960 — Effect of Acute Fructose Load in Human · NA · completed
Other Federal University of Rio Grande do Sul trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03939130 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federal University of Rio Grande do Sul
- Last refreshed: 6 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03939130.
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