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CompletedNCT04613856Updated Nov 3, 2020

Water Bolus Volumes During Continuous Exercise in Heat

An interventional study of Hydration protocol - 237 mL water bolus and Hydration protocol - 500 mL water bolus in Dehydration (Physiology) and Hyperthermia, sponsored by State University of New York at Buffalo. Completed at 1 site in United States. Open to male participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-03.

Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Apr 2019, registered Oct 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Dehydration (Physiology)
  • Hyperthermia
03

In context

Dehydration

204 studies on the registry are indexed under Dehydration; 29 are open to participants now.

This study's enrollment of 16 is below the median of 43 across 147 interventional studies indexed under Dehydration.

Browse Dehydration studies →

Lead sponsor

State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male
  • 18-39 y old
  • Self-reported to be healthy

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    Current Best Practice - 237 mL water bolus

    Other: Hydration protocol - 237 mL water bolus

  • Experimental
    New Intervention - 500 mL water bolus

    Other: Hydration protocol - 500 mL water bolus

Interventions

  • OtherHydration protocol - 237 mL water bolus

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

  • OtherHydration protocol - 500 mL water bolus

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

06

What researchers measure

Primary outcomes

  1. Percent body mass loss

    Percent body mass loss after water intake

    Time frame: 2 hours

  2. Core temperature

    Core temperature after water intake

    Time frame: 2 hours

07

Study locations

1 site
  • Center for Research and Exercise in Special Environments
    Buffalo, New York 14214, United States
08

References and documents

Individual participant data

Plan to share: No — IPD data can be provided upon written request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04613856
Lead sponsor
State University of New York at Buffalo
Responsible party
Riana Pryor (Principal Investigator, State University of New York at Buffalo) — Principal investigator
First posted
Nov 3, 2020
Start date
Apr 17, 2019
Primary completion
Mar 12, 2020
Completion
Mar 12, 2020
Last update
Nov 3, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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