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Clinical Trials/NCT04310514
NCT04310514UnknownNot Applicable

Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers

Medical University of Gdansk1 site in 1 country30 target enrollmentStarted: March 9, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
Change in urinary AKI biomarkers (urianry NGAL, urinary KIM -1, urinary cystatin-C) after physical exercise

Study Overview

Brief Summary

Rehydration during and after physical exercise is essential to avoid acute kidney injury.

Soft drinks are commonly used during exercise. High intake of carbohydrates is leading to obesity and metabolic disorders. Fructose intake is leading to uric acid abnormalities and kidney injury.

30 healthy soccer players will be studied. During four training sessions subjects will intake 500 ml 7% soft drinks containing glucose, fructose, saccharose or xylitol.

Changes in acute kidney injury markers, markers of kidney tubular function as well as changes in CRP, glucose, cholesterol and uric acid levels will be studied..

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Diagnostic
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •age above 18 years
  • •well-trained soccer players
  • •informed consent

Exclusion Criteria

  • •chronic diseases, especially kidney problems
  • •sigificant changes in urinalysis
  • •creatinine level above normal values

Arms & Interventions

Experimental: glucose - fructose - xylitol - saccharose

Active Comparator
  • glucose 35 g (500ml of 7% solution);
  • fructose 35 g (500ml of 7% solution);
  • xylitol 35 g (500ml of 7% solution);
  • saccharose 35 g (500ml of 7% solution)

Intervention: Fructose/glucose/xylitol/saccharose (Dietary Supplement)

Experimental: fructose - glucose - saccharose - xylitol

Active Comparator
  • glucose 35 g (500ml of 7% solution);
  • fructose 35 g (500ml of 7% solution);
  • xylitol 35 g (500ml of 7% solution);
  • saccharose 35 g (500ml of 7% solution)

Intervention: Fructose/glucose/xylitol/saccharose (Dietary Supplement)

Experimental: xylitol - saccharose - glucose - fructose

Active Comparator
  • glucose 35 g (500ml of 7% solution);
  • fructose 35 g (500ml of 7% solution);
  • xylitol 35 g (500ml of 7% solution);
  • saccharose 35 g (500ml of 7% solution)

Intervention: Fructose/glucose/xylitol/saccharose (Dietary Supplement)

Experimental: saccharose - xylitol - fructose - glucose

Active Comparator
  • glucose 35 g (500ml of 7% solution);
  • fructose 35 g (500ml of 7% solution);
  • xylitol 35 g (500ml of 7% solution);
  • saccharose 35 g (500ml of 7% solution)

Intervention: Fructose/glucose/xylitol/saccharose (Dietary Supplement)

Outcomes

Primary Outcomes

Change in urinary AKI biomarkers (urianry NGAL, urinary KIM -1, urinary cystatin-C) after physical exercise

Time Frame: after 60-90 min of pysical exercise

Changes in fractional uric acid excretion

Time Frame: after 60-90 min of pysical exercise

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wojciech Wolyniec

Principal Investigator

Medical University of Gdansk

Study Sites (1)

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