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临床试验/NCT05989607
NCT05989607已完成不适用

Kids Rehydration During Exercise (ROAR East)

University of Hartford2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年8月10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
20
试验地点
2
主要终点
Net fluid balance (according to body weight change) from baseline to 3 hours post exercise

研究概览

简要总结

The present study aims to measure the impact of consuming a lower sugar flavored water compared to an equal amount of plain water during exercise on selected rehydration markers in healthy children. Participants will complete two experimental visits designed to examine the differentiating effects of one of two selected beverages (1) lower sugar flavored water beverage and 2) plain water) on certain hydration markers and related perceptual variables during repeated bouts of exercise in a warm environment to induce mild dehydration.

详细描述

Parents of adolescent children have demonstrated a preference to remove added and larger boluses of sugar from their child's diet in accordance with accumulating health concerns. While forms of sugar are often included in oral rehydration solutions, evidence demonstrates that electrolytes such as sodium are the predominant beverage ingredients contributing to rehydration. Determining the efficacy and preference when thirsty of a flavored water beverage (with lower sugar content), compared to plain water could guide future beverage selection to achieve rehydration in young people.

Protocol:

This is a randomized, counter-balanced, cross-over design study. Thirty participants will be voluntarily enrolled (defined as the completion of assent and successful screening). Upon enrollment, participants will be familiarized to the study procedures: exercise, dietary consumption, urine sample collection, body weight measurement, bioelectrical impedance spectroscopy (BIS) analysis, and perceptual questionnaire completion. Participants will be scheduled to complete two experimental visits within three weeks of one another. Each experimental visit is designed to examine the differentiating effects of one of two selected beverages (1) lower sugar flavored water beverage and 2) plain water) on certain hydration markers and related perceptual variables during repeated bouts of exercise.

Day Before study:

Participants will consume a standardized frozen dinner (provided by the researchers) and consume at least 250 ml (8oz) of water after dinner. Food and beverages other than water will be prohibited following dinner.

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
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Girls and boys age 8 to 10y
  • Willing and able to walk and cycle at a moderate intensity for sequential brief exercise periods (separated by a brief rest period) repeatedly (3x) in a warm environment (80-85°F)
  • Body weight ≤85th percentile for their age group

排除标准

  • History of conditions or current use of medications known to alter body water balance (diabetes, renal disease, SSRI's, etc.)
  • Current or recent (past two weeks) illness involving fever, diarrhea, and/or GI discomfort
  • Physical or mental disabilities and injuries that would prevent participation in moderate-intensity treadmill walking/jogging and cycling
  • Previous diagnosis of heat stroke
  • Body weight ≥86th percentile for their age group

结局指标

主要结局

Net fluid balance (according to body weight change) from baseline to 3 hours post exercise

时间窗: baseline to 3 hours post exercise

Net fluid balance (according to body weight change) attributable to sweat/body water losses/additions by control of food/beverage intake and urine/fecal output; post 3 hour post exercise body weight (180min) - baseline body weight (0 minutes) = net fluid balance.

次要结局

  • Total and compartmental body water change (according to bioelectrical impedance spectroscopy) from baseline to 3 hours post-exercise(baseline to 3 hours post exercise)
  • Hydration-related perceptual variable change (thirst, mouth dryness, taste pleasantness) from baseline to 3 hours post-exercise(baseline to 3 hours post exercise)
  • Hydration status change (according to urine concentration) from baseline to 3 hours post exercise(baseline to 3 hours post exercise)

研究者

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

Colleen Munoz

PhD, Associate Professor, Hydration Health Center Director

University of Hartford

研究点 (2)

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