NCT04155372

Brief Summary

The purpose of the present study is to investigate the effect of different rate of fluid consumption on post-exercise rehydration.

Trial Health

35
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 Dec 2019

Shorter than P25 for not_applicable

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

November 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

November 5, 2019

Last Update Submit

November 6, 2019

Conditions

Dehydration

Keywords

sports nutritiondehydrationsports medicinerehydrationingestion rate

Outcome Measures

Primary Outcomes (6)

  • specific gravity of urine(SG)

    dehydration: \>= 1.020

    Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period

  • Osmolality(Urine)

    dehydration: \>= 700 mosm/kg

    Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period

  • Osmolality(Blood)

    dehydration: \>= 290 mosm/kg

    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.

    Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period

  • sodium(blood)

    135\~145mEq/L

    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

    Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period

Study Arms (3)

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.

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.

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.

Procedure: Different Fluid Ingestion Rate

Interventions

Different Fluid Ingestion RatePROCEDURE

The participants ingested sports drink in a volume equivalent to 150% of BW loss, in 30 min, 60 min, or 90min.

30min60min90min

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • JIAN-YU LIN

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JIAN-YU LIN

CONTACT

886-7-342-2121linchainyu0822@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 7, 2019

Study Start

December 1, 2019

Primary Completion

July 1, 2020

Study Completion

August 1, 2020

Last Updated

November 8, 2019

Record last verified: 2019-11