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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04310514
Other study ID # 04-0532/09/776
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 9, 2020
Est. completion date December 31, 2020

Study information

Verified date March 2020
Source Medical University of Gdansk
Contact Wojciech Wolyniec, MD,PhD
Phone 48 600942998
Email wolyniecwojtek@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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..


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Fructose/glucose/xylitol/saccharose
Intervention: rehydration with glucose solution. Glucose will be administered at a dose of 35 mg (500 ml of 7% solution) taken orally once, in the middle of soccer training session, at approximately 10.00 a.m. Intervention: rehydration with fructose solution. Fructose will be administered at a dose of 35 mg (500 ml of 7% solution) taken orally once, in the middle of soccer training session, at approximately 10.00 a.m. Intervention: rehydration with xylitol solution. Xylitol will be administered at a dose of 35 mg (500 ml of 7% solution) taken orally once, in the middle of soccer training session, at approximately 10.00 a.m. Intervention: rehydration with sucrose solution Saccharose will be administered at a dose of 35 mg (500 ml of 7% solution) taken orally once, in the middle of soccer training session, at approximately 10.00 a.m.

Locations

Country Name City State
Poland Medical University of Gdansk Gdansk

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in urinary AKI biomarkers (urianry NGAL, urinary KIM -1, urinary cystatin-C) after physical exercise after 60-90 min of pysical exercise
Primary Changes in fractional uric acid excretion after 60-90 min of pysical exercise
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