NCT04613856

Brief Summary

Hydration is important to all individuals including occupational workers who complete physical activity in the heat. Current best practice guidelines suggest drinking a cup of water every 15-20 minutes during activity in a hot environment, but research shows this may not be ideal for best maintaining hydration. The goal of this study is to determine if larger, more frequent water boluses better maintain hydration than smaller, less frequent water boluses during moderate intensity physical activity in the heat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

October 30, 2020

Last Update Submit

November 2, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Percent body mass loss

    Percent body mass loss after water intake

    2 hours

  • Core temperature

    Core temperature after water intake

    2 hours

Study Arms (2)

Current Best Practice - 237 mL water bolus

ACTIVE COMPARATOR
Other: Hydration protocol - 237 mL water bolus

New Intervention - 500 mL water bolus

EXPERIMENTAL
Other: Hydration protocol - 500 mL water bolus

Interventions

Subjects consume 237 mL of water every 20 minutes during 2 hours of high intensity work in the heat.

Current Best Practice - 237 mL water bolus

Subjects consume 500 mL of water every 40 minutes during 2 hours of high intensity work in the heat.

New Intervention - 500 mL water bolus

Eligibility Criteria

Age18 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • y old
  • Self-reported to be healthy

You may not qualify if:

  • Female
  • Not within defined age range
  • History of any cardiovascular, neurologic, or metabolic disease
  • Current tobacco use or regular use within the last 2 years.
  • Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
  • Inability to follow the rules of the protocols or understand the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Research and Exercise in Special Environments

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

DehydrationHyperthermia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBody Temperature ChangesSigns and SymptomsHeat Stress DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomized, counterbalanced, crossover study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 3, 2020

Study Start

April 17, 2019

Primary Completion

March 12, 2020

Study Completion

March 12, 2020

Last Updated

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

IPD data can be provided upon written request.

Locations