ClinicalTrials.gg
CompletedNCT05989607Updated Apr 11, 2025

Kids Rehydration During Exercise

An interventional study of Lower sugar flavored water and Plain Water in Dehydration in Children and Dehydration Following Exertion (Disorder), sponsored by University of Hartford. Completed at 1 site in United States. Open to participants aged 8 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-11.

Sponsored by University of Hartford · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
8 Years to 10 Years
Sex
All
01

Study summary

The present study aims to measure the impact of consuming a lower sugar flavored water compared to an equal amount of plain water during exercise on selected rehydration markers in healthy children. Participants will complete two experimental visits designed to examine the differentiating effects of one of two selected beverages (1) lower sugar flavored water beverage and 2) plain water) on certain hydration markers and related perceptual variables during repeated bouts of exercise in a warm environment to induce mild dehydration.

Read the detailed description

Parents of adolescent children have demonstrated a preference to remove added and larger boluses of sugar from their child's diet in accordance with accumulating health concerns. While forms of sugar are often included in oral rehydration solutions, evidence demonstrates that electrolytes such as sodium are the predominant beverage ingredients contributing to rehydration. Determining the efficacy and preference when thirsty of a flavored water beverage (with lower sugar content), compared to plain water could guide future beverage selection to achieve rehydration in young people.

Protocol:

This is a randomized, counter-balanced, cross-over design study. Thirty participants will be voluntarily enrolled (defined as the completion of assent and successful screening). Upon enrollment, participants will be familiarized to the study procedures: exercise, dietary consumption, urine sample collection, body weight measurement, bioelectrical impedance spectroscopy (BIS) analysis, and perceptual questionnaire completion. Participants will be scheduled to complete two experimental visits within three weeks of one another. Each experimental visit is designed to examine the differentiating effects of one of two selected beverages (1) lower sugar flavored water beverage and 2) plain water) on certain hydration markers and related perceptual variables during repeated bouts of exercise.

Day Before study:

Participants will consume a standardized frozen dinner (provided by the researchers) and consume at least 250 ml (8oz) of water after dinner. Food and beverages other than water will be prohibited following dinner.

Study Day:

Participants will arrive at each study visit fasted (no food or beverages within the previous eight hours, except 250 ml of plain water two to three hours prior to the experimental visit). In the event that the participant did not fast, their visit will be rescheduled. Only one visit reschedule will be offered throughout the course of their participation. Upon arrival, participants will then consume a standardized breakfast. Following breakfast (approximately 15min following completion) they will provide a urine sample, the investigators will record body weight and measure body fluids by BIS (in a prone position), and they will complete questionnaires (with appropriate guidance and in visual analogue scale format) about mouth dryness, taste pleasantness, stomach fullness, and thirst. All body weight measurements will be taken with as minimal clothing as possible; only the participant's parent/guardian will be with the participant for this measurement to protect privacy. Each participant will wear the same amount of clothing for every body weight measurement during their individual participation.

Subsequently, the participant will enter a warm room with a controlled/recorded temperature between 28-30°C (80-85°F). Then the participant will undergo a 3 hour intermittent walk, cycle, rest protocol. During the 3-h period, each participant will complete the following one hour test, three sequential times:

  • 10 min walking on the treadmill at 70% of age-predicted max heart rate (\~140 bpm)
  • 5 min rest
  • 10 min cycling on the cycle ergometer at 70 of age-predicted max heart rate (\~140 bpm)
  • 35 min rest

During the 3-h period, participants will be provided with the fluid volume equating to 2% of body mass losses (as determined by ongoing individual body weight difference measurements) during each one hour test (water or a lower sugar flavored water beverage); anticipated as \~200ml). During this time body weight, and urine samples, BIS, and perceptual data via questionnaires will be collected (prior to and following each exercise bout).

02

Conditions studied

  • Dehydration in Children
  • Dehydration Following Exertion (Disorder)

Browse trials for

03

In context

Dehydration

201 studies on the registry are indexed under Dehydration; 28 are open to participants now.

This study's enrollment of 20 is below the median of 43 across 145 interventional studies indexed under Dehydration.

Browse Dehydration studies →

Lead sponsor

University of Hartford is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Girls and boys age 8 to 10y
  • Willing and able to walk and cycle at a moderate intensity for sequential brief exercise periods (separated by a brief rest period) repeatedly (3x) in a warm environment (80-85°F)
  • Body weight ≤85th percentile for their age group

Exclusion criteria

Exclusion Criteria:

  • History of conditions or current use of medications known to alter body water balance (diabetes, renal disease, SSRI's, etc.)
  • Current or recent (past two weeks) illness involving fever, diarrhea, and/or GI discomfort
  • Physical or mental disabilities and injuries that would prevent participation in moderate-intensity treadmill walking/jogging and cycling
  • Previous diagnosis of heat stroke
  • Body weight ≥86th percentile for their age group
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Low Sugar Flavored Water

    A commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).

    Other: Lower sugar flavored water

  • Active comparator
    Plain Water

    Plain water (bottled, spring).

    Other: Plain Water

Interventions

  • OtherLower sugar flavored water

    A commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).

  • OtherPlain Water

    Commercially available bottled, spring water.

06

What researchers measure

Primary outcomes

  1. Net fluid balance (according to body weight change) from baseline to 3 hours post exercise

    Net fluid balance (according to body weight change) attributable to sweat/body water losses/additions by control of food/beverage intake and urine/fecal output; post 3 hour post exercise body weight (180min) - baseline body weight (0 minutes) = net fluid balance.

    Time frame: baseline to 3 hours post exercise

Secondary outcomes

  1. Hydration status change (according to urine concentration) from baseline to 3 hours post exercise

    Hydration status change according to urine concentration measurement (osmolality, specific gravity, and color); 3 hour post-exercise urine concentration (180min) - baseline urine concentration (0 minutes) = hydration status change.

    Time frame: baseline to 3 hours post exercise

  2. Total and compartmental body water change (according to bioelectrical impedance spectroscopy) from baseline to 3 hours post-exercise

    Total and compartmental body water change (according to bioelectrical impedance spectroscopy); 3 hour post exercise kilohertz (180 minutes) - baseline kilohertz (0 minutes) = total and compartmental body water change.

    Time frame: baseline to 3 hours post exercise

  3. Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness) from baseline to 3 hours post-exercise

    Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness; via visual analog scale, measured in millimeters, where higher millimeters represents greater perception of that variable); 3 hours post-exercise millimeters (180min) - baseline millimeters (0min) = hydration-related perceptual variable change

    Time frame: baseline to 3 hours post exercise

07

Study locations

1 site
  • University of Hartford
    West Hartford, Connecticut 06117, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2023 to primary completion in Oct 2023, 2 months.

Of 65 non-industry interventional studies with no phase under Dehydration, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 2 months is below that.

Counting every sponsor, half of 73 studies reached it within 9 months; a quarter within 5 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2023
First posted
Aug 14, 2023
StartActual
Aug 10, 2023
Primary completionActual
Oct 31, 2023
CompletionActual
Dec 13, 2023
Last update
Apr 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05989607
Lead sponsor
University of Hartford
Collaborators
Kraft Heinz Company, Arizona State University
Responsible party
Colleen Munoz (PhD, Associate Professor, Hydration Health Center Director, University of Hartford) — Principal investigator
First posted
Aug 14, 2023
Start date
Aug 10, 2023
Primary completion
Oct 31, 2023
Completion
Dec 13, 2023
Last update
Apr 11, 2025

Study contacts

Colleen Munoz, PhD
principal investigator · University of Hartford

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion