NCT05174793

Brief Summary

The purpose of this study was to determine if rapid changes in hydration status could be determined by urine color expressed in CIE color space

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

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

March 15, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

November 22, 2021

Last Update Submit

December 13, 2021

Conditions

Dehydration

Outcome Measures

Primary Outcomes (1)

  • can urine color expressed in CIE color space reflect hydration status

    urine color expressed in CIE color space

    one hour dehydration and rehydration

Study Arms (2)

dehydration to rehydration

EXPERIMENTAL

subjects were rehydrated following 2% dehydration

Other: dehydration and rehydration

euhydration to dehydration

EXPERIMENTAL

subjects were dehydrated by 2% with exercise in the heat

Other: dehydration and rehydration

Interventions

dehydration and rehydrationOTHER

dehydration and rehydration

dehydration to rehydrationeuhydration to dehydration

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age,
  • no previous heat intolerance

You may not qualify if:

  • \- Pregnant women,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92120-1805, United States

Location

MeSH Terms

Conditions

Dehydration

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Michael Buono

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: urine color was measured during dehydration and rehydration
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 22, 2021

First Posted

January 3, 2022

Study Start

March 15, 2020

Primary Completion

November 15, 2020

Study Completion

November 15, 2020

Last Updated

January 3, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)