Dehydration and Population Health
1 other identifier
observational
40
1 country
1
Brief Summary
The primary aim of this study is to assess cardiovascular changes (blood pressure, heart rate, electrocardiogram/ECG) in response to mild fluid-restriction dehydration and subsequent rehydration in healthy young and old people. Secondary aims are to assess changes in body composition, mood, and hunger in response to mild dehydration and rehydration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2020
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
March 3, 2020
CompletedFirst Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2022
CompletedAugust 6, 2020
August 1, 2020
1.8 years
July 28, 2020
August 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Cardiovascular changes
Changes in QRS waveforms will be assessed using electrocardiograms (ECG) before and after dehydration (fluid restriction)
change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Secondary Outcomes (3)
Changes in perception of thirst and hunger
change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Changes in body composition
change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Changes in mood
change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Interventions
Study participants will refrain from drinking fluids overnight to facilitate 1-2% fluid loss from baseline
Eligibility Criteria
Healthy (i.e. does not take any regular prescription medications) adults between the ages of 18-70 years, who can walk comfortably on a treadmill for 1-hour (to enhance fluid loss before the rehydration period).
You may qualify if:
- Healthy (no regular prescription medication usage)
- Able to walk continuously on treadmill for 60 minutes
You may not qualify if:
- Confirmed or suspected pregnancy
- Chronic medical condition
- Regular prescription medication use
- Inability to walk continuously walk on a treadmill for 60 minutes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wayne State Universitylead
- University of Chicagocollaborator
Study Sites (1)
#055 Education Building, Wayne State University
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tamara D Hew(-Butler), PhD
Wayne State University
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Exercise and Sport Science
Study Record Dates
First Submitted
July 28, 2020
First Posted
August 6, 2020
Study Start
March 3, 2020
Primary Completion
December 31, 2021
Study Completion
November 6, 2022
Last Updated
August 6, 2020
Record last verified: 2020-08