Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers

NCT ID: NCT04310514

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2020-12-31

Brief Summary

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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..

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Experimental: glucose - fructose - xylitol - saccharose

* 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)

Group Type ACTIVE_COMPARATOR

Fructose/glucose/xylitol/saccharose

Intervention Type DIETARY_SUPPLEMENT

1. 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.
2. 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.
3. 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.
4. 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.

Experimental: fructose - glucose - saccharose - xylitol

* 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)

Group Type ACTIVE_COMPARATOR

Fructose/glucose/xylitol/saccharose

Intervention Type DIETARY_SUPPLEMENT

1. 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.
2. 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.
3. 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.
4. 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.

Experimental: xylitol - saccharose - glucose - fructose

* 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)

Group Type ACTIVE_COMPARATOR

Fructose/glucose/xylitol/saccharose

Intervention Type DIETARY_SUPPLEMENT

1. 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.
2. 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.
3. 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.
4. 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.

Experimental: saccharose - xylitol - fructose - glucose

* 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)

Group Type ACTIVE_COMPARATOR

Fructose/glucose/xylitol/saccharose

Intervention Type DIETARY_SUPPLEMENT

1. 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.
2. 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.
3. 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.
4. 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.

Interventions

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Fructose/glucose/xylitol/saccharose

1. 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.
2. 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.
3. 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.
4. 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Wojciech Wolyniec

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcin Renke, prof

Role: STUDY_CHAIR

Medical University of Gdansk

Locations

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Medical University of Gdansk

Gdansk, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Wojciech Wolyniec, MD,PhD

Role: CONTACT

48 600942998

References

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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.

Reference Type DERIVED
PMID: 36338481 (View on PubMed)

Other Identifiers

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04-0532/09/776

Identifier Type: -

Identifier Source: org_study_id

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