The Role of Hydration on Exercise Performance - ODIN (ODIN)
Primary Purpose
Dehydration
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iv fluid infusion
Sponsored by
About this trial
This is an interventional prevention trial for Dehydration
Eligibility Criteria
Inclusion Criteria:
- Cycling Racing History category 3 or higher USA cycling certification
- maximal oxygen uptake >55 ml/kg/min
Exclusion Criteria:
- History of heat stroke
- Renal, cardiovascular, metabolic diseases
- Regular medication
Sites / Locations
- University of Arkansas - HPER
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Euhydration - no thirst
Dehydration - no Thirst
Arm Description
Outcomes
Primary Outcome Measures
5km - Cycling Time Trial
Time to completion 5 km cycling time trial in the heat
Secondary Outcome Measures
Rectal Temperature
Body core temperature at the end of the 5 km time trial
Full Information
NCT ID
NCT02980939
First Posted
November 30, 2016
Last Updated
May 27, 2017
Sponsor
University of Arkansas, Fayetteville
1. Study Identification
Unique Protocol Identification Number
NCT02980939
Brief Title
The Role of Hydration on Exercise Performance - ODIN
Acronym
ODIN
Official Title
The Role of Hydration on Exercise Performance - ODIN
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
March 18, 2017 (Actual)
Study Completion Date
March 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arkansas, Fayetteville
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Euhydration - no thirst
Arm Type
Placebo Comparator
Arm Title
Dehydration - no Thirst
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
iv fluid infusion
Intervention Description
Intravenous isotonic saline infusion
Primary Outcome Measure Information:
Title
5km - Cycling Time Trial
Description
Time to completion 5 km cycling time trial in the heat
Time Frame
2hour
Secondary Outcome Measure Information:
Title
Rectal Temperature
Description
Body core temperature at the end of the 5 km time trial
Time Frame
2hour
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Cycling Racing History category 3 or higher USA cycling certification
maximal oxygen uptake >55 ml/kg/min
Exclusion Criteria:
History of heat stroke
Renal, cardiovascular, metabolic diseases
Regular medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros A Kavouras, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas - HPER
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Role of Hydration on Exercise Performance - ODIN
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