Acute Kidney InjuryNCT04310514
Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers
A study testing Fructose/glucose/xylitol/saccharose in people with Acute Kidney Injury, run by Medical University of Gdansk at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Fructose/glucose/xylitol/saccharose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 9 Mar 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age above 18 years
- well-trained soccer players
- informed consent
Who cannot join
- chronic diseases, especially kidney problems
- sigificant changes in urinalysis
- creatinine level above normal values
Trial locations and contacts
1 site in 1 country.
About this study
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..
- Conditions
- Acute Kidney Injury
- Being tested
- Fructose/glucose/xylitol/saccharose
- Keywords
- biomarker, albuminuria, uric acid
- Medical subject headings
- Acute Kidney Injury, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructose/glucose/xylitol/saccharoseDietary supplement
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Dietary Supplement: Fructose/glucose/xylitol/saccharose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary AKI biomarkers (urianry NGAL, urinary KIM -1, urinary cystatin-C) after physical exercise
Measured: after 60-90 min of pysical exercise
Changes in fractional uric acid excretion
Measured: after 60-90 min of pysical exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start9 Mar 2020
- Primary completion1 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Wolyniec, Medical University of Gdansk
- Investigators
- Marcin Renke, prof, Study chair, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310514
- Sponsor's protocol ID
- 04-0532/09/776
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36338481
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rehydration During Physical Exercise on Acute Kidney Injury Biomarkers
- ClinicalTrials.gov ID
- NCT04310514
- Acronym / sponsor ID
- 04-0532/09/776
- Conditions
- Acute Kidney Injury
- Keywords
- biomarker, albuminuria, uric acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: glucose - fructose - xylitol - saccharose | Active comparator | Dietary Supplement: Fructose/glucose/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) |
| Experimental: fructose - glucose - saccharose - xylitol | Active comparator | Dietary Supplement: Fructose/glucose/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) |
| Experimental: xylitol - saccharose - glucose - fructose | Active comparator | Dietary Supplement: Fructose/glucose/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) |
| Experimental: saccharose - xylitol - fructose - glucose | Active comparator | Dietary Supplement: Fructose/glucose/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) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age above 18 years
- well-trained soccer players
- informed consent
Key exclusion criteria (3 listed)
- chronic diseases, especially kidney problems
- sigificant changes in urinalysis
- creatinine level above normal values
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fructose/glucose/xylitol/saccharose1. 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. | Dietary supplement | Experimental: fructose - glucose - saccharose - xylitol, Experimental: glucose - fructose - xylitol - saccharose, Experimental: saccharose - xylitol - fructose - glucose, Experimental: xylitol - saccharose - glucose - fructose |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Derived from this study: PubMed 36338481Wolyniec 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin Renke, prof study chair
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose/glucose/xylitol/saccharose in people with Acute Kidney Injury, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wojciech Wolyniec, MD,PhD (48 600942998, wolyniecwojtek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04310514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.