The Impact of Adequate Water Intake on Exercise Performance and Mood in Women and Men (WEXMO)

August 23, 2023 updated by: Arizona State University

Dehydration is defined as the state of water deficit due to excessive water losses and/or small water intake. Underhydration is the result of inadequate water intake leading to activation of water hormonal homeostasis, characterized by elevated vasopressin, lower urinary output, and concentrated urine without any measurable changes in total body water. It is well established that dehydration (water deficit) decreases exercise performance and worsens mood, mainly in women. However, the impact of increased water intake in underhydrated individuals on their exercise capacity and mood is not known.

The aim of the proposed study is to investigate the impact of increased water intake in underhydrated individuals on aerobic exercise performance and mood in both women and men.

Study Overview

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Interdisciplinary Science and Technology Building 8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults
  • Residence in Arizona

Exclusion Criteria:

  • Use of diuretics
  • Use of anti-depressive medication
  • Current pregnancy or lactation
  • Current use of injectable insulin
  • Diagnosed with irritable bowel syndrome
  • Do not pass the Physical Activity Readiness Questionnaire for Everyone (PAR-Q) screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Euhydrated
Afternoon urine osmolality < 800 mmol/kg or urine specific gravity < 1.020.
The subjects that are classified as euhydrated will be asked to maintain high water intake for one week to ensure proper hydration. A 2-mile run will be completed before and after the 7-day intervention.
Experimental: Underhydrated
Afternoon urine osmolality ≥ 800 mmol/kg or urine specific gravity ≥ 1.020.
The underhydrated individuals will be instructed to increase their water intake for one week in order to meet the following two criteria: a) urinate at least 7 times per day and b) have straw-like color urine. A 2-mile run will be completed before and after the 7-day intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-mile run-time (min)
Time Frame: Day 1
Day 1
2-mile run-time (min)
Time Frame: Day 8
Day 8
Mood
Time Frame: Pre-trial on day 1
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Pre-trial on day 1
Mood
Time Frame: Post-trial on day 1
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Post-trial on day 1
Mood
Time Frame: Pre-trial on day 8
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Pre-trial on day 8
Mood
Time Frame: Post-trial on day 8
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Post-trial on day 8
Urine osmolality (mmol/kg)
Time Frame: 4 - 8 PM on day 0
4 - 8 PM on day 0
Urine osmolality (mmol/kg)
Time Frame: 4 - 8 PM on day 7
4 - 8 PM on day 7
Urine osmolality (mmol/kg)
Time Frame: Upon waking (first morning sample) on day 1
Upon waking (first morning sample) on day 1
Urine osmolality (mmol/kg)
Time Frame: Upon waking (first morning sample) on day 8
Upon waking (first morning sample) on day 8
Urine specific gravity
Time Frame: 4 - 8 PM on day 0
4 - 8 PM on day 0
Urine specific gravity
Time Frame: 4 - 8 PM on day 7
4 - 8 PM on day 7
Urine specific gravity
Time Frame: Upon waking (first morning sample) on day 1
Upon waking (first morning sample) on day 1
Urine specific gravity
Time Frame: Upon waking (first morning sample) on day 8
Upon waking (first morning sample) on day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine color
Time Frame: 4 - 8 PM on day 0
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
4 - 8 PM on day 0
Urine color
Time Frame: 4 - 8 PM on day 7
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
4 - 8 PM on day 7
Urine color
Time Frame: Upon waking (first morning sample) on day 1
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Upon waking (first morning sample) on day 1
Urine color
Time Frame: Upon waking (first morning sample) on day 8
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Upon waking (first morning sample) on day 8
Thirst perception
Time Frame: 4 - 8 PM on day 0
175 mm visual analog scale. Minimum score: 0 (not thirsty at all). Maximum score: 175 (extremely thirsty). A higher score indicates a worse outcome (e.g., more thirsty).
4 - 8 PM on day 0
Thirst perception
Time Frame: 4 - 8 PM on day 7
175 mm visual analog scale. Minimum score: 0 (not thirsty at all). Maximum score: 175 (extremely thirsty). A higher score indicates a worse outcome (e.g., more thirsty).
4 - 8 PM on day 7
Thirst perception
Time Frame: Upon waking (first morning sample) on day 1
175 mm visual analog scale. Minimum score: 0 (not thirsty at all). Maximum score: 175 (extremely thirsty). A higher score indicates a worse outcome (e.g., more thirsty).
Upon waking (first morning sample) on day 1
Thirst perception
Time Frame: Upon waking (first morning sample) on day 8
175 mm visual analog scale. Minimum score: 0 (not thirsty at all). Maximum score: 175 (extremely thirsty). A higher score indicates a worse outcome (e.g., more thirsty).
Upon waking (first morning sample) on day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2021

Primary Completion (Actual)

April 26, 2023

Study Completion (Actual)

April 26, 2023

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

September 1, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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