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NCT02206581 Clinical Trial

Using Hydration Monitor to Detect Changes in the Hydration Status Athletes

Dehydration Clinical Trial

Official title:
The Validity of Ultrasound Velocity to Detect Changes in the Hydration Status of Male and Female Athletes During Acute Dehydration and Rehydration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02206581
Other study ID # HME-01
Secondary ID 2R44AG042990
Status Completed
Phase N/A
First received July 30, 2014
Last updated January 20, 2016
Start date October 2014
Est. completion date December 2015

Study information
Verified date January 2016
Source Artann Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The study will aim to evaluate the correlation between changes in ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing an acute dehydration and rehydration. The study will also test the hypothesis that body dehydration is a generalized physiological process equally affected all body muscles by comparing the data obtained on calf and biceps muscles.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date December 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- male or female athletes

- ages 18-25 years old

Exclusion Criteria:

- open wounds or rashes on calf testing area

- active skin infection

- pregnant female subjects

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Device:
• Hydration Monitor

Locations
Country Name City State
United States Appalachian State University Boone North Carolina

Sponsors (4)
Lead Sponsor Collaborator
Artann Laboratories Appalachian State University, National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To observe statistically significant changes in ultrasound velocity associated with acute dehydration 2 hours No
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