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临床试验/NCT04213456
NCT04213456进行中(未招募)不适用

Double Blind, Randomized, Placebo Controlled Pilot Study to Evaluate the Effect of Nutritional Supplementation on Physical Activity Performance of Young Soccer Players

Rabin Medical Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
2
主要终点
Agility test score

研究概览

简要总结

Research has clearly shown that lacking sufficient calories, macro- and micro-nutrients may impair an athlete's training adaptations, while athletes who consume a balanced diet that meets energy needs can enhance physiological training adaptations. Maintaining an energy and nutrient deficient diet during training may lead to loss of muscle mass, strength, and bone mineral density, in addition to an increased susceptibility to illness and injuries, disturbances in immune, endocrine and reproductive function, and an increased prevalence of overreaching and/or overtraining. In children and adolescent athletes, an insufficient diet may additionally result in impaired physical growth. Incorporating good dietary practices as part of a training program is one way to help optimize training adaptations and prevent overtraining.

Based on this, nutritional supplementation is an effective and safe approach for attaining the high nutritional requirements of adolescent athletes, to help them maintain healthy growth. Nutritional supplementation could also improve their body composition, sport performance and general health. The primary objective of the proposed study is to evaluate the effect of dietary supplement versus placebo on growth and physical activity performance in young athletes. A total of 50 young soccer players (25 in each group) will participate in this Double blind, randomized, placebo controlled study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Young soccer players aged 8-15 years old

排除标准

  • Diagnosis of GH Deficiency or treatment with GH
  • Any known chronic disease or dysmorphic syndrome including: organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems, gastrointestinal disease including malabsorption and bone dysplasia.

研究组 & 干预措施

Nutritional supplementation

Experimental

Powder added to water,high protein and multi vitamin and minerals

干预措施: Nutritional Sport Formula (Dietary Supplement)

Placebo

Placebo Comparator

Low caloric formula (Powder added to water), without added vitamins and minerals.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Agility test score

时间窗: at 4 months

Change in Agility test score between baseline and 4 months(agility is the ability to change the direction of the body rapidly and is a result of a combination of strength, speed, balance and coordination)

Height SDS (standard deviation score)

时间窗: at 4 months

Change in standard deviation score of participant's height between baseline and 4 months

10m sprint score

时间窗: at 4 months

Change in 10m sprint score between baseline and 4 months (test the speed and acceleration of the player)

20m sprint score

时间窗: at 4 months

Change in 20m sprint score between baseline and 4 months (test the speed and acceleration of the player)

Countermovement Jump (CMJ) score

时间窗: at 4 months

Change in Countermovement Jump (CMJ) score between baseline and 4 months (assess explosive strength of the lower extremity muscles)

The Yo-Yo Intermittent Recovery Test Level 1 (Yo-Yo IR1) score

时间窗: at 4 months

Change in the Yo-Yo IR1 score between baseline and 4 months (The Yo-Yo IR test measure the ability to recover from intense exercise)

次要结局

  • weight-SDS(at 4 months)
  • BMI-SDS(at 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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