Dehydration (Physiology)NCT04502238
Dehydration and Population Health
An observational study of Dehydration (Physiology), run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dehydration (Physiology)
- What is being tested?
- Fluid restriction
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2020to 6 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: 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).
Who may be able to join
- Healthy (no regular prescription medication usage)
- Able to walk continuously on treadmill for 60 minutes
Who cannot join
- Confirmed or suspected pregnancy
- Chronic medical condition
- Regular prescription medication use
- Inability to walk continuously walk on a treadmill for 60 minutes
Trial locations and contacts
1 site in 1 country.
United States1 site
#055 Education Building, Wayne State University
Detroit, Michigan, 48202
About this study
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.
Read the detailed description
PARTICIPANTS: Forty healthy (no regular prescription medication use) male and females, between the ages of 18-70 years, will be recruited for this randomized-control cross-over study. Ideally, the investigators hope to recruit twenty "younger" (18-50) and twenty "older" (50-70) participants for this pilot study.
All participants will be required to participate in two separate trials (a control and dehydration-rehydration trial, in randomized order), separated by at least a week. All menstruating females will be tested during the follicular phase of their menstrual cycle (i.e. within the first 14 days after the onset of the menstrual period). All participants will present to the lab in the evening for pre-testing and then in the morning for mid-testing/post-testing. With both pre-testing and mid-testing/post-testing each taking ~90 minutes each, plus 12-hours of fluid deprivation or regular food/fluid intake overnight, the total time participating in collective study activities would be approximately 30-hours (~15 hours per trial).
PROCEDURES: For each of the two study trials, participants will come to the lab in the evening for pre-testing and then the following morning for mid-testing/post-testing (one trial). Hydration status will be assessed using blood (venipuncture), urine (spot sample), body weight, and thirst rating (100mm visual analogue scale). Cardiovascular variables will be assessed via heart rate, ECG, and blood pressure. Body composition will be measured using a dual energy x-ray absorptiometry (DXA) scan. Mood will be assessed using the Profile of Mood States (POMS) questionnaire.
Once the participants present to the lab, pre-test blood, urine, body weight and composition, mood and thirst/sodium/hunger ratings will be obtained. Then, to enhance sweat water losses, each participant will be asked to walk on a motorized treadmill at a self-selected speed for 60-minutes.
During the Dehydration-Rehydration trial, participants will be asked to refrain from ingesting any fluid (fluid restriction) for at least 12-hours overnight (i.e. from leaving the lab that evening until coming into the lab the next morning) to facilitate dehydration. After mid-testing, the participants will be allowed free access to water for a 60-minute rehydration period to quench their thirst ("ad libitum" drinking). At the end of this 60-minute rehydration period, post-test measures will be repeated. During the control trial, the participants can eat and drink as they please during the 12-hour overnight period.
- Conditions
- Dehydration (Physiology)
- Being tested
- Fluid restriction
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid restrictionOther
Study participants will refrain from drinking fluids overnight to facilitate 1-2% fluid loss from baseline
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular changes
Changes in QRS waveforms will be assessed using electrocardiograms (ECG) before and after dehydration (fluid restriction)
Measured: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Secondary outcomes (3)
Changes in perception of thirst and hunger
Thirst and hunger will be assessed on a VAS (visual analogue scale) before and after dehydration (fluid restriction)
Measured: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Changes in body composition
Body composition (bone, lean, and fat mass) will be assessed using dual energy x-ray absorptiometry (DXA) scans before and after dehydration (fluid restriction)
Measured: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Changes in mood
Mood will be assessed using the POMS (profile of mood states) survey before and after dehydration (fluid restriction)
Measured: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start3 Mar 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion6 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dehydration (Physiology)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Responsible party
- Principal investigator, Tamara Hew-Butler DPM, PhD, FACSM, Wayne State University
- Investigators
- Tamara D Hew(-Butler), PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502238
- Sponsor's protocol ID
- 1908002467
- Status last verified
- Aug 2020
- First submitted
- 28 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data shared, especially with regards to our University of Chicago collaborators, will be de-identified. Participants will be assigned an unidentified subject number once consent form is signed, and all data collected and imported into a spreadsheet will be de-identified. The "master list" which contains the link between each participant's name and the assigned subject number will be placed in a locked cabinet in Dr Hew-Butler's office, separate from the actual data and signed informed Consent forms. All participant information will remain strictly confidential and will not be identified in any subsequent publications or presentation of the results.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dehydration and Population Health
- ClinicalTrials.gov ID
- NCT04502238
- Acronym / sponsor ID
- 1908002467
- Conditions
- Dehydration (Physiology)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 6 Nov 2022 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PARTICIPANTS: Forty healthy (no regular prescription medication use) male and females, between the ages of 18-70 years, will be recruited for this randomized-control cross-over study. Ideally, the investigators hope to recruit twenty "younger" (18-50) and twenty "older" (50-70) participants for this pilot study.
All participants will be required to participate in two separate trials (a control and dehydration-rehydration trial, in randomized order), separated by at least a week. All menstruating females will be tested during the follicular phase of their menstrual cycle (i.e. within the first 14 days after the onset of the menstrual period). All participants will present to the lab in the evening for pre-testing and then in the morning for mid-testing/post-testing. With both pre-testing and mid-testing/post-testing each taking ~90 minutes each, plus 12-hours of fluid deprivation or regular food/fluid intake overnight, the total time participating in collective study activities would be approximately 30-hours (~15 hours per trial).
PROCEDURES: For each of the two study trials, participants will come to the lab in the evening for pre-testing and then the following morning for mid-testing/post-testing (one trial). Hydration status will be assessed using blood (venipuncture), urine (spot sample), body weight, and thirst rating (100mm visual analogue scale). Cardiovascular variables will be assessed via heart rate, ECG, and blood pressure. Body composition will be measured using a dual energy x-ray absorptiometry (DXA) scan. Mood will be assessed using the Profile of Mood States (POMS) questionnaire.
Once the participants present to the lab, pre-test blood, urine, body weight and composition, mood and thirst/sodium/hunger ratings will be obtained. Then, to enhance sweat water losses, each participant will be asked to walk on a motorized treadmill at a self-selected speed for 60-minutes.
During the Dehydration-Rehydration trial, participants will be asked to refrain from ingesting any fluid (fluid restriction) for at least 12-hours overnight (i.e. from leaving the lab that evening until coming into the lab the next morning) to facilitate dehydration. After mid-testing, the participants will be allowed free access to water for a 60-minute rehydration period to quench their thirst ("ad libitum" drinking). At the end of this 60-minute rehydration period, post-test measures will be repeated. During the control trial, the participants can eat and drink as they please during the 12-hour overnight period.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (2 listed)
- Healthy (no regular prescription medication usage)
- Able to walk continuously on treadmill for 60 minutes
Key exclusion criteria (4 listed)
- Confirmed or suspected pregnancy
- Chronic medical condition
- Regular prescription medication use
- Inability to walk continuously walk on a treadmill for 60 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid restrictionStudy participants will refrain from drinking fluids overnight to facilitate 1-2% fluid loss from baseline | Other | – |
Primary outcome
Cardiovascular changes
Time frame: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Changes in QRS waveforms will be assessed using electrocardiograms (ECG) before and after dehydration (fluid restriction)
3 secondary outcomes
Changes in perception of thirst and hunger
Time frame: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Changes in body composition
Time frame: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Changes in mood
Time frame: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: Undecided. All data shared, especially with regards to our University of Chicago collaborators, will be de-identified. Participants will be assigned an unidentified subject number once consent form is signed, and all data collected and imported into a spreadsheet will be de-identified. The "master list" which contains the link between each participant's name and the assigned subject number will be placed in a locked cabinet in Dr Hew-Butler's office, separate from the actual data and signed informed Consent forms. All participant information will remain strictly confidential and will not be identified in any subsequent publications or presentation of the results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara D Hew(-Butler), PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration (Physiology), run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular changes (time frame: change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020; AzTrials last refreshed its copy on 27 Oct 2026.