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临床试验/NCT02428127
NCT02428127已完成不适用

Efficacy of a Carbohydrate Drink on Speed, Agility and Power in School Going Children

GlaxoSmithKline2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Change from baseline in Agility fatigue index

研究概览

简要总结

The purpose of this study is to investigate the impact of a beverage containing carbohydrate powder fortified with micronutrients on agility, speed, and power in school going children

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Informed consent by participant's parents or legally accepted representative
  • Good general health
  • Non anemic children (Hb≥12 g/dl)
  • Academy/development level athlete (at least 3 activity sessions per week, for a minimum of 2 hours of activity in each session e.g. hockey, football, team sports)

排除标准

  • Child in care
  • Allergy/Intolerance to study materials
  • History of cardiovascular disorder, respiratory diseases, diabetes mellitus, serious infection/injuries/surgeries (within past 3 months)
  • Participation in any nutritional study in past 1 year
  • Substance abuse
  • Children on any kind of medication in past 1 month of screening

研究组 & 干预措施

Test

Experimental

20g Carbohydrate powder fortified with multiple micronutrients, reconstituted as a beverage in 200mL lukewarm water. This will be administered twice a day

干预措施: Carbohydrate beverage powder (Dietary Supplement)

Calorie matched protein powder

Active Comparator

20g Calorie matched protein powder with 80% protein, reconstituted as a beverage in 200mL lukewarm water. This will be administered twice a day

干预措施: Calorie matched beverage powder (Dietary Supplement)

Control

Placebo Comparator

200mL lukewarm water given twice a day

干预措施: Water (Other)

结局指标

主要结局

Change from baseline in Agility fatigue index

时间窗: Baseline and 4h post-baseline

Agility fatigue index (FI) will be calculated from Repeat Agility Performance Test, using 'Brower equipment'. This assessment includes a 24 meter agility run, repeated on 6 occasions, with every sprint and recovery interval lasting for 65 seconds (eg. if the first agility effort takes the participant 5 seconds, they will have 55 seconds to return to start line for a 5 seconds countdown before their second agility effort). Agility FI=\[100X(total agility time÷ideal agility time)\]-100. Here, ideal agility time is the best agility time for each participant multiplied by number of repetitions

次要结局

  • Change from baseline in Mean power output(Baseline and 4h post-baseline)
  • Change from baseline in Speed fatigue index(Baseline and 4h post-baseline)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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