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Dehydration in ChildrenNCT05989607

Kids Rehydration During Exercise

A study testing Lower sugar flavored water and Plain Water in people with Dehydration in Children and Dehydration Following Exertion (Disorder), run by University of Hartford at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 10 yearsHealthy volunteers can take part
What is being tested?
Lower sugar flavored water and Plain Water
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
10 Aug 2023to 13 Dec 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 8 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Hartford

    West Hartford, Connecticut, 06117

Other trials in United States

About this study

Official title: Kids Rehydration During Exercise (ROAR East)

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).

Being tested
Lower sugar flavored water, Plain Water

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lower sugar flavored waterOther

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

  • Plain WaterOther

    Commercially available bottled, spring water.

Study groups in NCT05989607
Study groupRoleWhat they receive
Low Sugar Flavored WaterExperimentalA commercially available low sugar flavored water (2.88kcal/100ml; 0.57(sugar) +0.03 (stevia)=0.60g/100ml; sodium 7.9mg/100ml).
Receives: Other: Lower sugar flavored water
Plain WaterActive comparatorPlain water (bottled, spring).
Receives: Other: Plain Water

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline to 3 hours post exercise

Secondary outcomes (3)
  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.

    Measured: 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.

    Measured: 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

    Measured: baseline to 3 hours post exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start10 Aug 2023
  3. Primary completion31 Oct 2023
  4. Study completion13 Dec 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
randomized, counter-balanced, cross-over design
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05989607
Sponsor's protocol ID
23-03-190
Status last verified
Apr 2025
First submitted
11 Jul 2023
Last updated
11 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lower sugar flavored water and Plain Water in people with Dehydration in Children and Dehydration Following Exertion (Disorder), run by University of Hartford 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 3 inclusion and 5 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 11 Apr 2025. 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?

Net fluid balance (according to body weight change) from baseline to 3 hours post exercise (time frame: baseline to 3 hours post exercise). 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 11 Apr 2025.

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