NCT02206581

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

July 30, 2014

Last Update Submit

January 20, 2016

Conditions

Dehydration

Keywords

dehydration

Outcome Measures

Primary Outcomes (1)

  • To observe statistically significant changes in ultrasound velocity associated with acute dehydration

    2 hours

Study Arms (1)

young healthy adult athletes

Hydration Monitor measurement of the ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing 3% acute dehydration and a 2-hr rehydration period

Device: Hydration Monitor

Interventions

Hydration MonitorDEVICE
young healthy adult athletes

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The subject pool will be comprised of 100 young, healthy, physically active male and female subjects.

You may qualify if:

  • male or female athletes
  • ages 18-25 years old

You may not qualify if:

  • open wounds or rashes on calf testing area
  • active skin infection
  • pregnant female subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Appalachian State University

Boone, North Carolina, 28608-2071, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 1, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

US(1)