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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05033665
Other study ID # STUDY00013646
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 26, 2021
Est. completion date April 26, 2023

Study information

Verified date August 2023
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 217
Est. completion date April 26, 2023
Est. primary completion date April 26, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Increase water consumption
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 consumption
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.

Locations

Country Name City State
United States Interdisciplinary Science and Technology Building 8 Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

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