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The Role of Hydration on Exercise Performance - ODIN (ODIN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980939
First Posted: December 2, 2016
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stavros Kavouras, University of Arkansas, Fayetteville
  Purpose
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.

Condition Intervention
Dehydration Other: iv fluid infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Role of Hydration on Exercise Performance - ODIN

Resource links provided by NLM:


Further study details as provided by Stavros Kavouras, University of Arkansas, Fayetteville:

Primary Outcome Measures:
  • 5km - Cycling Time Trial [ Time Frame: 2hour ]
    Time to completion 5 km cycling time trial in the heat


Secondary Outcome Measures:
  • Rectal Temperature [ Time Frame: 2hour ]
    Body core temperature at the end of the 5 km time trial


Enrollment: 11
Study Start Date: November 2016
Study Completion Date: March 18, 2017
Primary Completion Date: March 18, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Euhydration - no thirst Other: iv fluid infusion
Intravenous isotonic saline infusion
Experimental: Dehydration - no Thirst Other: iv fluid infusion
Intravenous isotonic saline infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980939


Locations
United States, Arkansas
University of Arkansas - HPER
Fayetteville, Arkansas, United States, 72701
Sponsors and Collaborators
University of Arkansas, Fayetteville
Investigators
Principal Investigator: Stavros A Kavouras, PhD University of Arkansas
  More Information

Responsible Party: Stavros Kavouras, Associate Professor, University of Arkansas, Fayetteville
ClinicalTrials.gov Identifier: NCT02980939     History of Changes
Other Study ID Numbers: 16-10-135
First Submitted: November 30, 2016
First Posted: December 2, 2016
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes