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Hydration Intervention in Children

Nutrition, Urinary Markers and Sleep Habits in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04265300
Enrollment
46
Registered
2020-02-11
Start date
2020-01-06
Completion date
2020-03-01
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration in Children

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTCreative Roots

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

Sponsors

University of Connecticut
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Hydration Status Change7 weeksChange in WUT Score (Weight Urine and Thirst)

Secondary

MeasureTime frameDescription
Sleep Change7 weeksChange in quantity
Cognitive functioning Change7 weeksChange in Go-no-go test score
Mood Change7 weeksChange in Modified Mood Questionnaire Score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026