Dehydration in ChildrenNCT04265300
Hydration Intervention in Children
A study testing Creative Roots in people with Dehydration in Children, run by University of Connecticut at 1 site in United States.
Trial summary
The investigators are conducting this research study to determine learn how daily habits and fluid choices impact children's health, sleep, cognitive function and mood. The investigators look to determine if a hydration intervention using an alternative beverage may impact these variables in children. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration in Children
- What is being tested?
- Creative Roots
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 1 Mar 2020
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- males and females
- aged 7-12 years old
- Guardians must also meet the criteria which is that
- 1) they shop at Whole Foods, Costco, or Trader Joe's
- 2) they use organic ingredients \&
- 3) they check the nutritional content on foods for their children.
Who cannot join
- prior diagnosis of cognitive or learning disabilities
- history of chronic kidney disease,
- diabetes
- sleep disorders
- use of medications that may alter water balance (e.g. diuretics, laxatives, antacids, anti-histamines, NSAIDs, blood pressure medication)
- mood and anxiety medications (e.g. antidepressants, anxiolytics, beta-blockers, ADHD medications).
- Other medications that can cause urine color changes include isoniazid, sulfasalazine, metronidazole, nitrofurantoin, amitriptyline, cimetidine, indomethacin, zaleplon, methocarbamol, metoclopramide, warfarin, rifampin, and phenazopyridine
- Participants who do not like the Creative Roots beverage
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Nutrition, Urinary Markers and Sleep Habits in Children
The investigators are conducting this research study to determine learn how daily habits and fluid choices impact children's health, sleep, cognitive function and mood. The investigators look to determine if a hydration intervention using an alternative beverage may impact these variables in children.
Maintaining an appropriate level of hydration throughout the day has multiple health benefits. Maintaining a desirable hydration status improves overall health and wellbeing (mood, reaction time, sleep quality, cognitive function, etc.) in adults, but negative health and mental effects of hypohydration are not fully understood in an adolescent population. Maintaining appropriate hydration in adolescents presents unique challenges with respect to schedule (e.g. the availability of fluid during the school day and after school activities) as well as ensuring the most beneficial beverage choice. Adolescents can be very meticulous regarding their preferred beverage (e.g. choosing a sugary drink over water) and parents prefer their children consume the healthiest option for their food and beverages, often times leading to conflict.
Read more
Therefore the purpose/goal of the proposed study is to determine if a hydration intervention using an alternative sweetened beverage will improve hydration and other overall health (e.g. cognitive function, sleep quality, mood etc.)
The investigators hypothesize, that by giving children an alternative tasty option, they will consume more fluids which may lead to improving and maintaining their chronic hydration state. Implementing a beverage intervention with a sweet alternative option (i.e. Creative Roots) could improve hydration levels in adolescents. In turn, possibly improving mood, reaction time, sleep quality, and cognitive function. All of which are vital in the overall development of the adolescent.
- Conditions
- Dehydration in Children
- Being tested
- Creative Roots
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creative RootsDietary supplement
The Creative Roots beverage is a coconut water-based drink with three flavors Mixed Berry, Watermelon Lemonade, and Peach Mango. The ingredients are as follows and are the same for all three flavors: water, coconut water concentrate, citric acid, stevia leaf extract, natural flavor, rosemary extract (to preserve flavor). Contains: coconut
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention provided |
| Creative Roots | Experimental | The intervention group will receive Creative Roots beverages and be instructed to have at least one drink (251mL) available at each meal (i.e. breakfast, lunch, and dinner) and drink as much as they would like throughout the day (i.e. ad libitum) of either Creative Roots or any other beverage they would normally consume. Subjects will be asked the keep their empty Creative Roots bottles to return them to the lab. Subjects will be instructed to refrigerate the beverages for better taste, and to refrigerate the beverages after opening. Receives: Dietary Supplement: Creative Roots |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydration Status Change
Change in WUT Score (Weight Urine and Thirst)
Measured: 7 weeks
Secondary outcomes (4)
Sleep Change
Change in quantity
Measured: 7 weeks
Cognitive functioning Change
Change in Go-no-go test score
Measured: 7 weeks
Cognitive functioning Change
Change in modified flanker task score
Measured: 7 weeks
Mood Change
Change in Modified Mood Questionnaire Score
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start6 Jan 2020
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas J Casa, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265300
- Sponsor's protocol ID
- H19-212
- Status last verified
- Jun 2020
- First submitted
- 3 Feb 2020
- Last updated
- 16 Jun 2020
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition, Urinary Markers and Sleep Habits in Children
- ClinicalTrials.gov ID
- NCT04265300
- Acronym / sponsor ID
- H19-212
- Conditions
- Dehydration in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 11 Feb 2020 (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 investigators are conducting this research study to determine learn how daily habits and fluid choices impact children's health, sleep, cognitive function and mood. The investigators look to determine if a hydration intervention using an alternative beverage may impact these variables in children.
Maintaining an appropriate level of hydration throughout the day has multiple health benefits. Maintaining a desirable hydration status improves overall health and wellbeing (mood, reaction time, sleep quality, cognitive function, etc.) in adults, but negative health and mental effects of hypohydration are not fully understood in an adolescent population. Maintaining appropriate hydration in adolescents presents unique challenges with respect to schedule (e.g. the availability of fluid during the school day and after school activities) as well as ensuring the most beneficial beverage choice. Adolescents can be very meticulous regarding their preferred beverage (e.g. choosing a sugary drink over water) and parents prefer their children consume the healthiest option for their food and beverages, often times leading to conflict.
Therefore the purpose/goal of the proposed study is to determine if a hydration intervention using an alternative sweetened beverage will improve hydration and other overall health (e.g. cognitive function, sleep quality, mood etc.)
The investigators hypothesize, that by giving children an alternative tasty option, they will consume more fluids which may lead to improving and maintaining their chronic hydration state. Implementing a beverage intervention with a sweet alternative option (i.e. Creative Roots) could improve hydration levels in adolescents. In turn, possibly improving mood, reaction time, sleep quality, and cognitive function. All of which are vital in the overall development of the adolescent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention provided |
| Creative Roots | Experimental | Dietary Supplement: Creative RootsThe intervention group will receive Creative Roots beverages and be instructed to have at least one drink (251mL) available at each meal (i.e. breakfast, lunch, and dinner) and drink as much as they would like throughout the day (i.e. ad libitum) of either Creative Roots or any other beverage they would normally consume. Subjects will be asked the keep their empty Creative Roots bottles to return them to the lab. Subjects will be instructed to refrigerate the beverages for better taste, and to refrigerate the beverages after opening. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- males and females
- aged 7-12 years old
- Guardians must also meet the criteria which is that
Key exclusion criteria (8 listed)
- prior diagnosis of cognitive or learning disabilities
- history of chronic kidney disease,
- diabetes
- sleep disorders
- use of medications that may alter water balance (e.g. diuretics, laxatives, antacids, anti-histamines, NSAIDs, blood pressure medication)
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 |
|---|---|---|
| Creative RootsThe Creative Roots beverage is a coconut water-based drink with three flavors Mixed Berry, Watermelon Lemonade, and Peach Mango. The ingredients are as follows and are the same for all three flavors: water, coconut water concentrate, citric acid, stevia leaf extract, natural flavor, rosemary extract (to preserve flavor). Contains: coconut | Dietary supplement | Creative Roots |
Primary outcome
Hydration Status Change
Time frame: 7 weeks
Change in WUT Score (Weight Urine and Thirst)
4 secondary outcomes
Sleep Change
Time frame: 7 weeks
Cognitive functioning Change
Time frame: 7 weeks
Cognitive functioning Change
Time frame: 7 weeks
Mood Change
Time frame: 7 weeks
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 16 Jun 2020.
- 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 Creative Roots in people with Dehydration in Children, run by University of Connecticut 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 6 inclusion and 8 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 16 Jun 2020. 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?
Hydration Status Change (time frame: 7 weeks). 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 16 Jun 2020.