- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05033665
The Impact of Adequate Water Intake on Exercise Performance and Mood in Women and Men (WEXMO)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Interdisciplinary Science and Technology Building 8
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00013646
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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