NCT04310514

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..

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 9, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 9, 2020

Last Update Submit

March 16, 2020

Conditions

Keywords

biomarkeralbuminuriauric acid

Outcome Measures

Primary Outcomes (2)

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

    after 60-90 min of pysical exercise

  • Changes in fractional uric acid excretion

    after 60-90 min of pysical exercise

Study Arms (4)

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)

Dietary Supplement: Fructose/glucose/xylitol/saccharose

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)

Dietary Supplement: Fructose/glucose/xylitol/saccharose

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)

Dietary Supplement: Fructose/glucose/xylitol/saccharose

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)

Dietary Supplement: Fructose/glucose/xylitol/saccharose

Interventions

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 - xylitolExperimental: glucose - fructose - xylitol - saccharoseExperimental: saccharose - xylitol - fructose - glucoseExperimental: xylitol - saccharose - glucose - fructose

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Gdansk

Gdansk, Poland

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney InjuryAlbuminuria

Interventions

Fructose

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesProteinuriaUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Marcin Renke, prof

    Medical University of Gdansk

    STUDY CHAIR

Central Study Contacts

Wojciech Wolyniec, MD,PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 17, 2020

Study Start

March 9, 2020

Primary Completion

September 1, 2020

Study Completion

December 31, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations