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

Primary Purpose

Dehydration, Mood

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Increase water consumption
Maintain adequate water consumption
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dehydration

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Interdisciplinary Science and Technology Building 8

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Euhydrated

Underhydrated

Arm Description

Afternoon urine osmolality < 800 mmol/kg or urine specific gravity < 1.020.

Afternoon urine osmolality ≥ 800 mmol/kg or urine specific gravity ≥ 1.020.

Outcomes

Primary Outcome Measures

2-mile run-time (min)
2-mile run-time (min)
Mood
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Mood
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Mood
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Mood
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Urine osmolality (mmol/kg)
Urine osmolality (mmol/kg)
Urine osmolality (mmol/kg)
Urine osmolality (mmol/kg)
Urine specific gravity
Urine specific gravity
Urine specific gravity
Urine specific gravity

Secondary Outcome Measures

Urine color
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Urine color
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Urine color
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Urine color
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Thirst perception
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).
Thirst perception
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).
Thirst perception
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).
Thirst perception
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).

Full Information

First Posted
August 25, 2021
Last Updated
August 23, 2023
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05033665
Brief Title
The Impact of Adequate Water Intake on Exercise Performance and Mood in Women and Men
Acronym
WEXMO
Official Title
The Impact of Adequate Water Intake on Exercise Performance and Mood in Women and Men
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
April 26, 2023 (Actual)
Study Completion Date
April 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration, Mood

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Euhydrated
Arm Type
Active Comparator
Arm Description
Afternoon urine osmolality < 800 mmol/kg or urine specific gravity < 1.020.
Arm Title
Underhydrated
Arm Type
Experimental
Arm Description
Afternoon urine osmolality ≥ 800 mmol/kg or urine specific gravity ≥ 1.020.
Intervention Type
Behavioral
Intervention Name(s)
Increase water consumption
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Maintain adequate water consumption
Intervention Description
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.
Primary Outcome Measure Information:
Title
2-mile run-time (min)
Time Frame
Day 1
Title
2-mile run-time (min)
Time Frame
Day 8
Title
Mood
Description
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Time Frame
Pre-trial on day 1
Title
Mood
Description
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Time Frame
Post-trial on day 1
Title
Mood
Description
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Time Frame
Pre-trial on day 8
Title
Mood
Description
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Time Frame
Post-trial on day 8
Title
Urine osmolality (mmol/kg)
Time Frame
4 - 8 PM on day 0
Title
Urine osmolality (mmol/kg)
Time Frame
4 - 8 PM on day 7
Title
Urine osmolality (mmol/kg)
Time Frame
Upon waking (first morning sample) on day 1
Title
Urine osmolality (mmol/kg)
Time Frame
Upon waking (first morning sample) on day 8
Title
Urine specific gravity
Time Frame
4 - 8 PM on day 0
Title
Urine specific gravity
Time Frame
4 - 8 PM on day 7
Title
Urine specific gravity
Time Frame
Upon waking (first morning sample) on day 1
Title
Urine specific gravity
Time Frame
Upon waking (first morning sample) on day 8
Secondary Outcome Measure Information:
Title
Urine color
Description
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Time Frame
4 - 8 PM on day 0
Title
Urine color
Description
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Time Frame
4 - 8 PM on day 7
Title
Urine color
Description
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Time Frame
Upon waking (first morning sample) on day 1
Title
Urine color
Description
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Time Frame
Upon waking (first morning sample) on day 8
Title
Thirst perception
Description
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).
Time Frame
4 - 8 PM on day 0
Title
Thirst perception
Description
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).
Time Frame
4 - 8 PM on day 7
Title
Thirst perception
Description
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).
Time Frame
Upon waking (first morning sample) on day 1
Title
Thirst perception
Description
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).
Time Frame
Upon waking (first morning sample) on day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Interdisciplinary Science and Technology Building 8
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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