Hydration Intervention in Children

NCT04265300 | Completed

• 1 other identifier: H19-212
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration in Children

Outcome Measures

Primary Outcomes (1)

• Hydration Status Change

  Change in WUT Score (Weight Urine and Thirst)

  7 weeks

Secondary Outcomes (4)

• Sleep Change

  7 weeks

• Cognitive functioning Change

  7 weeks

• Cognitive functioning Change

  7 weeks

• Mood Change

  7 weeks

Study Arms (2)

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.

Dietary Supplement: Creative Roots

Interventions

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

Creative Roots

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• males and females
• aged 7-12 years old
• Guardians must also meet the criteria which is that
• \) they shop at Whole Foods, Costco, or Trader Joe's
• \) they use organic ingredients \&
• \) they check the nutritional content on foods for their children.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 11, 2020
• Study Start: January 6, 2020
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)