Hydration Intervention in Children

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.

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 Overview

• Status: Completed
• Conditions: Dehydration in Children
• Intervention / Treatment: Dietary supplement: Creative Roots

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention provided
Experimental: Creative Roots; 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.	Dietary supplement: Creative 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydration Status Change	Change in WUT Score (Weight Urine and Thirst)	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Change	Change in quantity	7 weeks
Cognitive functioning Change	Change in Go-no-go test score	7 weeks
Cognitive functioning Change	Change in modified flanker task score	7 weeks
Mood Change	Change in Modified Mood Questionnaire Score	7 weeks

Collaborators and Investigators

• Sponsor: University of Connecticut

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 13, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: H19-212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No