Dehydration in ChildrenROARNCT06084702
Children Rehydration During Exercise
A study testing Rehydration with plain water and Rehydration Drink in people with Dehydration in Children, run by Arizona State University at 1 site in United States.
Trial summary
The low fluid intake in combination with a high intake of sugar-sweetened beverages (SSB) by children is a significant concern among public health professionals. Therefore reformulation of existing commercially available beverages has been suggested as one of the strategies to change SSB beverage behaviors of… Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration in Children
- What is being tested?
- Rehydration with plain water and Rehydration Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2023to 6 Apr 2024
- 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 10 years
- Willing to walk and cycle in a warm environment (80-85°F)
- Body weight ≤85th percentile for their age group
Who cannot join
- History of conditions known to alter body water balance (diabetes, renal disease, etc.)
- Drugs that (may) influence hydration status (including Selective serotonin reuptake inhibitor (SSRI), ADHD medication, diuretics and corticoids)
- Physical or mental disabilities 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
Interdisciplinary Science and Technology Building 8
Phoenix, Arizona, 85004
About this study
Official title: Kids Rehydration During Exercise
The low fluid intake in combination with a high intake of sugar-sweetened beverages (SSB) by children is a significant concern among public health professionals. Therefore reformulation of existing commercially available beverages has been suggested as one of the strategies to change SSB beverage behaviors of children. It has been suggested that lack of flavor in plain water is one of the factors of low water intake in children. Therefore, the addition of a flavor to a low-carbohydrate beverage might increase and facilitate the voluntary fluid intake in children, and result in more effective rehydration during and after exercise. The present study aims to examine if a lower sugar flavored water will improve voluntary hydration in children that perform multiple exercise bouts within a period of 3 hours.
Read the detailed description
Subject will enter a warm room with a temperature between 28-30°C (80-85°F). Then, subjects will undergo a 3-hour walk, cycle, and rest protocol. The exercise intensity is based on 70% of the subject's predicted heart rate using the formula: 220 beats per minute (bpm) - 10 years of age = 210 bpm, and 70% equals 147 bpm). This is an intensity in which the subject has an elevated breathing frequency but can still talk. During the 3-h period subject will complete the following one-hour test three times:
- 10 min walking on the treadmill at 70% of predicted max heart rate (~147 bpm)
- 5 min rest
- 10 min cycling on the cycle ergometer at 70% of predicted max heart rate (~147 bpm)
- 35 min rest
During the 3-h period, subjects will have free access to fluids Body weight and urine samples will be collected during the experiement
- Conditions
- Dehydration in Children
- Being tested
- Rehydration with plain water, Rehydration Drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehydration with plain waterOther
Plain water without calories, sweetener, or electolytes
Rehydration DrinkOther
Roaring Water. An electrolyte drink with low Carbohydrate content
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | Plain Water Receives: Other: Rehydration with plain water |
| Low Carb drink | Experimental | Roaring Water Receives: Other: Rehydration Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid intake during the 3 hour period
ad-libitum fluid intake
Measured: 1, 2, and 3 hours of the protocol
Net Fluid Balance based on body weight changes
Measured: 1, 2, and 3 hours of the protocol
Secondary outcomes (3)
Urine output
Cumulative urine volume
Measured: 1, 2 and 3 hour of the protocol
urine osmolality
Measured: 1, 2, and 3 hour
Urine osmotic excretion
Measured: 1, 2, and 3 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start14 Oct 2023
- Primary completion6 Apr 2024
- Study completion6 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dehydration in ChildrenStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Kraft Heinz Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084702
- Sponsor's protocol ID
- FP00036850
- Acronym
- ROAR
- Status last verified
- May 2024
- First submitted
- 23 Aug 2023
- Last updated
- 17 May 2024
- 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 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kids Rehydration During Exercise
- ClinicalTrials.gov ID
- NCT06084702
- Acronym / sponsor ID
- ROAR / FP00036850
- Conditions
- Dehydration in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Kraft Heinz Company
- Study start
- 14 Oct 2023 (actual)
- Primary completion
- 6 Apr 2024 (actual)
- Study completion
- 6 Apr 2024 (actual)
- First posted
- 16 Oct 2023 (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.
The low fluid intake in combination with a high intake of sugar-sweetened beverages (SSB) by children is a significant concern among public health professionals. Therefore reformulation of existing commercially available beverages has been suggested as one of the strategies to change SSB beverage behaviors of children. It has been suggested that lack of flavor in plain water is one of the factors of low water intake in children. Therefore, the addition of a flavor to a low-carbohydrate beverage might increase and facilitate the voluntary fluid intake in children, and result in more effective rehydration during and after exercise. The present study aims to examine if a lower sugar flavored water will improve voluntary hydration in children that perform multiple exercise bouts within a period of 3 hours.
Detailed description
Subject will enter a warm room with a temperature between 28-30°C (80-85°F). Then, subjects will undergo a 3-hour walk, cycle, and rest protocol. The exercise intensity is based on 70% of the subject's predicted heart rate using the formula: 220 beats per minute (bpm) - 10 years of age = 210 bpm, and 70% equals 147 bpm). This is an intensity in which the subject has an elevated breathing frequency but can still talk. During the 3-h period subject will complete the following one-hour test three times:
- 10 min walking on the treadmill at 70% of predicted max heart rate (~147 bpm)
- 5 min rest
- 10 min cycling on the cycle ergometer at 70% of predicted max heart rate (~147 bpm)
- 35 min rest
During the 3-h period, subjects will have free access to fluids Body weight and urine samples will be collected during the experiement
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Crossover
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Other: Rehydration with plain waterPlain Water |
| Low Carb drink | Experimental | Other: Rehydration DrinkRoaring Water |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Girls and boys age 8 to 10 years
- Willing to walk and cycle in a warm environment (80-85°F)
- Body weight ≤85th percentile for their age group
Key exclusion criteria (5 listed)
- History of conditions known to alter body water balance (diabetes, renal disease, etc.)
- Drugs that (may) influence hydration status (including Selective serotonin reuptake inhibitor (SSRI), ADHD medication, diuretics and corticoids)
- Physical or mental disabilities 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
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 |
|---|---|---|
| Rehydration with plain waterPlain water without calories, sweetener, or electolytes | Other | Water |
| Rehydration DrinkRoaring Water. An electrolyte drink with low Carbohydrate content | Other | Low Carb drink |
Primary outcome
Fluid intake during the 3 hour period
Time frame: 1, 2, and 3 hours of the protocol
ad-libitum fluid intake
Net Fluid Balance based on body weight changes
Time frame: 1, 2, and 3 hours of the protocol
3 secondary outcomes
Urine output
Time frame: 1, 2 and 3 hour of the protocol
urine osmolality
Time frame: 1, 2, and 3 hour
Urine osmotic excretion
Time frame: 1, 2, and 3 hour
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 17 May 2024.
- Individual participant dataSharing planned: No
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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 Rehydration with plain water and Rehydration Drink in people with Dehydration in Children, 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 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 17 May 2024. 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. Some participants in this study may receive a placebo. 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?
Fluid intake during the 3 hour period (time frame: 1, 2, and 3 hours of the protocol). The study lists 2 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 17 May 2024.