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Completed

NCT Number: NCT04265300

Hydration Intervention 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.

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.

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Key information

Conditions

Dehydration in Children

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creative Roots

Dietary 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

Primary outcomes

  1. Hydration Status Change

    Time frame: 7 weeks

    Change in WUT Score (Weight Urine and Thirst)

Secondary outcomes

  1. Sleep Change

    Time frame: 7 weeks

    Change in quantity

  2. Cognitive functioning Change

    Time frame: 7 weeks

    Change in Go-no-go test score

  3. Cognitive functioning Change

    Time frame: 7 weeks

    Change in modified flanker task score

  4. Mood Change

    Time frame: 7 weeks

    Change in Modified Mood Questionnaire Score

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Official study title

Nutrition, Urinary Markers and Sleep Habits in Children

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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