NCT02980939

Brief Summary

During exercise in the heat, there is a need to replenish fluids in order to avoid dehydration and decrease the risk for heat illness. What drives this urge to drink is the thirst mechanism. Following ingestion of fluids, there is an inhibition of thirst before there is a replenishing of fluids. However, there is little scientific evidence of where thirst is inhibited, if this thirst inhibition is augmented by exercise and how thirst itself influence exercise performance. Further, during rehydration studies, it is very difficult to successfully blind a subject to their drinking/hydration protocol. Previous studies that have blinded a subject to their drinking have used various methods such as intravenous fluid administration and/or nasogastric tubes. Therefore, the purpose of this research is to examine the mechanistic roles thirst inhibition plays while exercising in the heat while undergoing intravenous fluid administration. Specific attention will be directed to the cardiovascular and thermoregulatory function of the individuals. All blood, cardiovascular, thermoregulatory, and perceptual measures are shown in the diagram below.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

November 30, 2016

Last Update Submit

May 27, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 5km - Cycling Time Trial

    Time to completion 5 km cycling time trial in the heat

    2hour

Secondary Outcomes (1)

  • Rectal Temperature

    2hour

Study Arms (2)

Euhydration - no thirst

PLACEBO COMPARATOR
Other: iv fluid infusion

Dehydration - no Thirst

EXPERIMENTAL
Other: iv fluid infusion

Interventions

Intravenous isotonic saline infusion

Dehydration - no ThirstEuhydration - no thirst

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cycling Racing History category 3 or higher USA cycling certification
  • maximal oxygen uptake \>55 ml/kg/min

You may not qualify if:

  • History of heat stroke
  • Renal, cardiovascular, metabolic diseases
  • Regular medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas - HPER

Fayetteville, Arkansas, 72701, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stavros A Kavouras, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 2, 2016

Study Start

November 1, 2016

Primary Completion

March 18, 2017

Study Completion

March 18, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations