DehydrationWEXMONCT05033665
The Impact of Adequate Water Intake on Exercise Performance and Mood in Women and Men
A study testing Increase water consumption and Maintain adequate water consumption in people with Dehydration and Mood, run by Arizona State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Mood
- What is being tested?
- Increase water consumption and Maintain adequate water consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to 26 Apr 2023
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- Residence in Arizona
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Interdisciplinary Science and Technology Building 8
Phoenix, Arizona, 85004
About this study
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.
- Conditions
- Dehydration, Mood
- Being tested
- Increase water consumption, Maintain adequate water consumption
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase water consumptionBehavioural
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.
Maintain adequate water consumptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Euhydrated | Active comparator | Afternoon urine osmolality < 800 mmol/kg or urine specific gravity < 1.020. Receives: Behavioral: Maintain adequate water consumption |
| Underhydrated | Experimental | Afternoon urine osmolality ≥ 800 mmol/kg or urine specific gravity ≥ 1.020. Receives: Behavioral: Increase water consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-mile run-time (min)
Measured: Day 1
2-mile run-time (min)
Measured: Day 8
Mood
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Measured: Pre-trial on day 1
Mood
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Measured: Post-trial on day 1
Mood
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Measured: Pre-trial on day 8
Mood
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Measured: Post-trial on day 8
Urine osmolality (mmol/kg)
Measured: 4 - 8 PM on day 0
Urine osmolality (mmol/kg)
Measured: 4 - 8 PM on day 7
Urine osmolality (mmol/kg)
Measured: Upon waking (first morning sample) on day 1
Urine osmolality (mmol/kg)
Measured: Upon waking (first morning sample) on day 8
Urine specific gravity
Measured: 4 - 8 PM on day 0
Urine specific gravity
Measured: 4 - 8 PM on day 7
Urine specific gravity
Measured: Upon waking (first morning sample) on day 1
Urine specific gravity
Measured: Upon waking (first morning sample) on day 8
Secondary outcomes (8)
Urine color
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Measured: 4 - 8 PM on day 0
Urine color
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Measured: 4 - 8 PM on day 7
Urine color
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Measured: Upon waking (first morning sample) on day 1
Urine color
Armstrong validated 8-color scale. Minimum score: 1. Maximum score: 8. A higher score indicates a worse outcome (e.g., dehydrated).
Measured: Upon waking (first morning sample) on day 8
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).
Measured: 4 - 8 PM on day 0
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).
Measured: 4 - 8 PM on day 7
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).
Measured: Upon waking (first morning sample) on day 1
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).
Measured: Upon waking (first morning sample) on day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start26 May 2021
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033665
- Sponsor's protocol ID
- STUDY00013646
- Acronym
- WEXMO
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2021
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Adequate Water Intake on Exercise Performance and Mood in Women and Men
- ClinicalTrials.gov ID
- NCT05033665
- Acronym / sponsor ID
- WEXMO / STUDY00013646
- Conditions
- Dehydration, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 5 Sep 2021 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Euhydrated | Active comparator | Behavioral: Maintain adequate water consumptionAfternoon urine osmolality < 800 mmol/kg or urine specific gravity < 1.020. |
| Underhydrated | Experimental | Behavioral: Increase water consumptionAfternoon urine osmolality ≥ 800 mmol/kg or urine specific gravity ≥ 1.020. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults
- Residence in Arizona
Key exclusion criteria (6 listed)
- Use of diuretics
- Use of anti-depressive medication
- Current pregnancy or lactation
- Current use of injectable insulin
- Diagnosed with irritable bowel syndrome
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 |
|---|---|---|
| Increase water consumptionThe 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. | Behavioural | Underhydrated |
| Maintain adequate water consumptionThe 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. | Behavioural | Euhydrated |
Primary outcome
2-mile run-time (min)
Time frame: Day 1
2-mile run-time (min)
Time frame: Day 8
Mood
Time frame: Pre-trial on day 1
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Mood
Time frame: Post-trial on day 1
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Mood
Time frame: Pre-trial on day 8
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Mood
Time frame: Post-trial on day 8
Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)
Urine osmolality (mmol/kg)
Time frame: 4 - 8 PM on day 0
Urine osmolality (mmol/kg)
Time frame: 4 - 8 PM on day 7
Urine osmolality (mmol/kg)
Time frame: Upon waking (first morning sample) on day 1
Urine osmolality (mmol/kg)
Time frame: Upon waking (first morning sample) on day 8
Urine specific gravity
Time frame: 4 - 8 PM on day 0
Urine specific gravity
Time frame: 4 - 8 PM on day 7
Urine specific gravity
Time frame: Upon waking (first morning sample) on day 1
Urine specific gravity
Time frame: Upon waking (first morning sample) on day 8
8 secondary outcomes
Urine color
Time frame: 4 - 8 PM on day 0
Urine color
Time frame: 4 - 8 PM on day 7
Urine color
Time frame: Upon waking (first morning sample) on day 1
Urine color
Time frame: Upon waking (first morning sample) on day 8
Thirst perception
Time frame: 4 - 8 PM on day 0
Thirst perception
Time frame: 4 - 8 PM on day 7
Thirst perception
Time frame: Upon waking (first morning sample) on day 1
Thirst perception
Time frame: Upon waking (first morning sample) on day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increase water consumption and Maintain adequate water consumption in people with Dehydration and Mood, run by Arizona 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 6 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: finished, as of the sponsor's last update on 24 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
2-mile run-time (min) (time frame: Day 1). The study lists 14 primary outcomes in all. 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 24 Aug 2023.