Effect of Different Fluid Ingestion Rate on Post-exercise Rehydration

November 6, 2019 updated by: LIN, JIAN-YU, Kaohsiung Veterans General Hospital.
The purpose of the present study is to investigate the effect of different rate of fluid consumption on post-exercise rehydration.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 20~35 years old male
  • Exercise 150 min per week
  • Without chronic disease or gastrointestinal surgery

Exclusion Criteria:

  • Injury
  • Answer "Yes" in part 1 of the Physical Activity Readiness Questionnaire(PAR-Q+)
  • Participate in other studies within one month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 30min
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.
Procedure: Different Fluid Ingestion Rate
The participants ingested sports drink in a volume equivalent to 150% of BW loss, in 30 min, 60 min, or 90min.
EXPERIMENTAL: 60min
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.
Procedure: Different Fluid Ingestion Rate
The participants ingested sports drink in a volume equivalent to 150% of BW loss, in 30 min, 60 min, or 90min.
EXPERIMENTAL: 90min
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.
Procedure: Different Fluid Ingestion Rate
The participants ingested sports drink in a volume equivalent to 150% of BW loss, in 30 min, 60 min, or 90min.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
Osmolality(Urine)
Time Frame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
dehydration: >= 700 mosm/kg
Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
Osmolality(Blood)
Time Frame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
dehydration: >= 290 mosm/kg
Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
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.
Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
sodium(blood)
Time Frame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
135~145mEq/L
Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
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
Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Veterans General Hospital.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kaohsiung Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: JIAN-YU LIN, Kaohsiung Veterans General Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VGHKS19-CT7-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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