Hydration Intervention in Children

Dehydration in Children Clinical Trial

Official title:

Nutrition, Urinary Markers and Sleep Habits in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265300
• Other study ID #: H19-212
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: March 1, 2020

Study information

• Verified date: June 2020
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Dehydration in Children

Intervention

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

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydration Status Change	Change in WUT Score (Weight Urine and Thirst)	7 weeks
Secondary	Sleep Change	Change in quantity	7 weeks
Secondary	Cognitive functioning Change	Change in Go-no-go test score	7 weeks
Secondary	Cognitive functioning Change	Change in modified flanker task score	7 weeks
Secondary	Mood Change	Change in Modified Mood Questionnaire Score	7 weeks