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Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers

Primary Purpose

Acute Kidney Injury

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Fructose/glucose/xylitol/saccharose
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Kidney Injury focused on measuring biomarker, albuminuria, uric acid

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of GdanskRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Experimental: glucose - fructose - xylitol - saccharose

Experimental: fructose - glucose - saccharose - xylitol

Experimental: xylitol - saccharose - glucose - fructose

Experimental: saccharose - xylitol - fructose - glucose

Arm Description

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)

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)

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)

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)

Outcomes

Primary Outcome Measures

Change in urinary AKI biomarkers (urianry NGAL, urinary KIM -1, urinary cystatin-C) after physical exercise
Changes in fractional uric acid excretion

Secondary Outcome Measures

Full Information

First Posted
March 9, 2020
Last Updated
March 16, 2020
Sponsor
Medical University of Gdansk
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1. Study Identification

Unique Protocol Identification Number
NCT04310514
Brief Title
Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers
Official Title
Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Gdansk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
biomarker, albuminuria, uric acid

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: glucose - fructose - xylitol - saccharose
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Experimental: fructose - glucose - saccharose - xylitol
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Experimental: xylitol - saccharose - glucose - fructose
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Experimental: saccharose - xylitol - fructose - glucose
Arm Type
Active Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Fructose/glucose/xylitol/saccharose
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Changes in fractional uric acid excretion
Time Frame
after 60-90 min of pysical exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wojciech Wolyniec, MD,PhD
Phone
48 600942998
Email
wolyniecwojtek@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Renke, prof
Organizational Affiliation
Medical University of Gdansk
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University of Gdansk
City
Gdańsk
Country
Poland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36338481
Citation
Wolyniec W, Szwarc A, Kasprowicz K, Zorena K, Jaskulak M, Renke M, Naczyk M, Ratkowski W. Impact of hydration with beverages containing free sugars or xylitol on metabolic and acute kidney injury markers after physical exercise. Front Physiol. 2022 Oct 20;13:841056. doi: 10.3389/fphys.2022.841056. eCollection 2022.
Results Reference
derived

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Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers

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