DehydrationNCT04155372
Effect of Different Fluid Ingestion Rate on Post-exercise Rehydration
A study testing Different Fluid Ingestion Rate in people with Dehydration, run by Kaohsiung Veterans General Hospital..
Trial summary
The purpose of the present study is to investigate the effect of different rate of fluid consumption on post-exercise rehydration. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Different Fluid Ingestion Rate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Aug 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20~35 years old male
- Exercise 150 min per week
- Without chronic disease or gastrointestinal surgery
Who cannot join
- Injury
- Answer "Yes" in part 1 of the Physical Activity Readiness Questionnaire(PAR-Q+)
- Participate in other studies within one month
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the present study is to investigate the effect of different rate of fluid consumption on post-exercise rehydration.
Read the detailed description
The body water deficits equivalent to 2% body mass might impair performance. Due to high exercise intensity, thermal environment, or rule limitation, athletes often in dehydration status post-exercise. Thus, how to rehydrate effectively to prepare the next game is important. The participants arrived to the lab euhydrated and were dehydrated to 2% of body weight by running. After a rest, they will ingest sports drink in a volume equivalent to 150% of BW loss in 30 min, 60 min, or 90 min. Urine and blood sample will be collected to evaluate hydration status.
- Conditions
- Dehydration
- Being tested
- Different Fluid Ingestion Rate
- Keywords
- sports nutrition, dehydration, sports medicine, rehydration, ingestion rate
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different Fluid Ingestion RateProcedure or surgery
The participants ingested sports drink in a volume equivalent to 150% of BW loss, in 30 min, 60 min, or 90min.
| Study group | Role | What they receive |
|---|---|---|
| 30min | Experimental | The participants arrived to the trials euhydrated and were dehydrated to 2% of body weight (BW) by running. After a rest, they ingested sports drink in a volume equivalent to 150% of BW loss in 30 min. Receives: Procedure: Different Fluid Ingestion Rate |
| 60min | Experimental | The participants arrived to the trials euhydrated and were dehydrated to 2% of body weight (BW) by running. After a rest, they ingested sports drink in a volume equivalent to 150% of BW loss in 60 min. Receives: Procedure: Different Fluid Ingestion Rate |
| 90min | Experimental | The participants arrived to the trials euhydrated and were dehydrated to 2% of body weight (BW) by running. After a rest, they ingested sports drink in a volume equivalent to 150% of BW loss in 90 min. Receives: Procedure: Different Fluid Ingestion Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
specific gravity of urine(SG)
dehydration: >= 1.020
Measured: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
Osmolality(Urine)
dehydration: >= 700 mosm/kg
Measured: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
Osmolality(Blood)
dehydration: >= 290 mosm/kg
Measured: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
Vasopressin
Vasopressin, also called antidiuretic hormone (ADH), arginine vasopressin (AVP) or argipressin, is a hormone synthesized as a peptide prohormone in neurons in the hypothalamus, and is converted to AVP. Increasing the water reabsorption and excretion of more concentrated urine.
Measured: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
sodium(blood)
135~145mEq/L
Measured: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
Body weight change
measure body weight at baseline, dehydration, 1st and 2nd hour in recovery period in kg
Measured: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study startDec 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Medical University
- Responsible party
- Principal investigator, LIN, JIAN-YU, Kaohsiung Veterans General Hospital.
- Investigators
- JIAN-YU LIN, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155372
- Sponsor's protocol ID
- VGHKS19-CT7-08
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Fluid Ingestion Rate on Post-exercise Rehydration
- ClinicalTrials.gov ID
- NCT04155372
- Acronym / sponsor ID
- VGHKS19-CT7-08
- Conditions
- Dehydration
- Keywords
- sports nutrition, dehydration, sports medicine, rehydration, ingestion rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Collaborators
- Kaohsiung Medical University
- Study start
- Dec 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 7 Nov 2019 (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.
The purpose of the present study is to investigate the effect of different rate of fluid consumption on post-exercise rehydration.
Detailed description
The body water deficits equivalent to 2% body mass might impair performance. Due to high exercise intensity, thermal environment, or rule limitation, athletes often in dehydration status post-exercise. Thus, how to rehydrate effectively to prepare the next game is important. The participants arrived to the lab euhydrated and were dehydrated to 2% of body weight by running. After a rest, they will ingest sports drink in a volume equivalent to 150% of BW loss in 30 min, 60 min, or 90 min. Urine and blood sample will be collected to evaluate hydration status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30min | Experimental | Procedure: Different Fluid Ingestion RateThe participants arrived to the trials euhydrated and were dehydrated to 2% of body weight (BW) by running. After a rest, they ingested sports drink in a volume equivalent to 150% of BW loss in 30 min. |
| 60min | Experimental | Procedure: Different Fluid Ingestion RateThe participants arrived to the trials euhydrated and were dehydrated to 2% of body weight (BW) by running. After a rest, they ingested sports drink in a volume equivalent to 150% of BW loss in 60 min. |
| 90min | Experimental | Procedure: Different Fluid Ingestion RateThe participants arrived to the trials euhydrated and were dehydrated to 2% of body weight (BW) by running. After a rest, they ingested sports drink in a volume equivalent to 150% of BW loss in 90 min. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20~35 years old male
- Exercise 150 min per week
- Without chronic disease or gastrointestinal surgery
Key exclusion criteria (3 listed)
- Injury
- Answer "Yes" in part 1 of the Physical Activity Readiness Questionnaire(PAR-Q+)
- Participate in other studies within one month
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 |
|---|---|---|
| Different Fluid Ingestion RateThe participants ingested sports drink in a volume equivalent to 150% of BW loss, in 30 min, 60 min, or 90min. | Procedure or surgery | 30min, 60min, 90min |
Primary outcome
specific gravity of urine(SG)
Time frame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
dehydration: >= 1.020
Osmolality(Urine)
Time frame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
dehydration: >= 700 mosm/kg
Osmolality(Blood)
Time frame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
dehydration: >= 290 mosm/kg
Vasopressin
Time frame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
Vasopressin, also called antidiuretic hormone (ADH), arginine vasopressin (AVP) or argipressin, is a hormone synthesized as a peptide prohormone in neurons in the hypothalamus, and is converted to AVP. Increasing the water reabsorption and excretion of more concentrated urine.
sodium(blood)
Time frame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
135~145mEq/L
Body weight change
Time frame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
measure body weight at baseline, dehydration, 1st and 2nd hour in recovery period in kg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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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.
JIAN-YU LIN principal investigator
Kaohsiung Veterans General Hospital.
Questions about this trial
What is this clinical trial studying?
A study testing Different Fluid Ingestion Rate in people with Dehydration, run by Kaohsiung Veterans General Hospital..
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 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 JIAN-YU LIN (886-7-342-2121 ext. 8248, linchainyu0822@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
specific gravity of urine(SG) (time frame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2019.