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临床试验/NCT04265300
NCT04265300已完成不适用

Nutrition, Urinary Markers and Sleep Habits in Children

University of Connecticut2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Hydration Status Change

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • prior diagnosis of cognitive or learning disabilities
  • history of chronic kidney disease,
  • 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

结局指标

主要结局

Hydration Status Change

时间窗: 7 weeks

Change in WUT Score (Weight Urine and Thirst)

次要结局

  • Mood Change(7 weeks)
  • Cognitive functioning Change(7 weeks)
  • Sleep Change(7 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas J Casa

Professor

University of Connecticut

研究点 (2)

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