Dehydration and Population Health

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.

Study Overview

• Status: Unknown
• Conditions: Dehydration (Physiology)
• Intervention / Treatment: Other: Fluid restriction

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • #055 Education Building, Wayne State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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).

Description

Inclusion Criteria:

• Healthy (no regular prescription medication usage)
• Able to walk continuously on treadmill for 60 minutes

Exclusion Criteria:

• Confirmed or suspected pregnancy
• Chronic medical condition
• Regular prescription medication use
• Inability to walk continuously walk on a treadmill for 60 minutes

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	change from baseline to dehydration (+13 hours) and then rehydration (+15 hours)

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: University of Chicago
• Investigators: Principal Investigator: Tamara D Hew(-Butler), PhD, Wayne State University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): November 6, 2022

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: 1908002467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No