NCT05033665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

1.9 years

First QC Date

August 25, 2021

Last Update Submit

August 23, 2023

Conditions

DehydrationMood

Outcome Measures

Primary Outcomes (14)

  • 2-mile run-time (min)

    Day 1

  • 2-mile run-time (min)

    Day 8

  • Mood

    Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)

    Pre-trial on day 1

  • Mood

    Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)

    Post-trial on day 1

  • Mood

    Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)

    Pre-trial on day 8

  • Mood

    Profile of Mood States questionnaire (POMS 2®-Adult Short, Multi-Health Systems Inc.)

    Post-trial on day 8

  • Urine osmolality (mmol/kg)

    4 - 8 PM on day 0

  • Urine osmolality (mmol/kg)

    4 - 8 PM on day 7

  • Urine osmolality (mmol/kg)

    Upon waking (first morning sample) on day 1

  • Urine osmolality (mmol/kg)

    Upon waking (first morning sample) on day 8

  • Urine specific gravity

    4 - 8 PM on day 0

  • Urine specific gravity

    4 - 8 PM on day 7

  • Urine specific gravity

    Upon waking (first morning sample) on day 1

  • Urine specific gravity

    Upon waking (first morning sample) on day 8

Secondary Outcomes (8)

  • Urine color

    4 - 8 PM on day 0

  • Urine color

    4 - 8 PM on day 7

  • Urine color

    Upon waking (first morning sample) on day 1

  • Urine color

    Upon waking (first morning sample) on day 8

  • Thirst perception

    4 - 8 PM on day 0

  • +3 more secondary outcomes

Study Arms (2)

Euhydrated

ACTIVE COMPARATOR

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

Behavioral: Maintain adequate water consumption

Underhydrated

EXPERIMENTAL

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

Behavioral: Increase water consumption

Interventions

Increase water consumptionBEHAVIORAL

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.

Underhydrated
Maintain adequate water consumptionBEHAVIORAL

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.

Euhydrated

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults
  • Residence in Arizona

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Interdisciplinary Science and Technology Building 8

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 5, 2021

Study Start

May 26, 2021

Primary Completion

April 26, 2023

Study Completion

April 26, 2023

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)