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临床试验/NCT06250556
NCT06250556招募中不适用

Creatine Supplementation in Young and Elite Female Football Players

University of Sao Paulo3 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
3
主要终点
kidney function

研究概览

简要总结

Creatine is an effective, inexpensive, and safe dietary supplement, which has been largely used in sports and clinical populations. However, creatine is much less studied in female athletes, with long-term data being particularly scant. This study aims to expand our knowledge on the effects of creatine supplementation in young (Under-20) and elite female football players. This study will comprise two experiments. The first one will be a randomized, controlled trial in which young athletes will be assigned into either creatine or placebo (n = 20). Before and 7 days after supplementation or placebo (4 x 5 g/d of Creapure or dextrose at same dose), athletes will perform a battery of performance tests. Blood and urinary biochemical parameters for assessing the safety of supplementation will be analyzed (creatinine, albuminuria, urea, sodium, potassium, liver enzymes, creatine kinase, hematology). Food intake will be assessed by means of 3-d 24-h dietary recalls. The second experiment will have a quasi-experimental design (i.e., pre-to-post), in which both young and elite football players (n = 70) will be supplemented with creatine (4 x 5 g/d for 7 days and then 5 days during the follow-up) and will be assessed for safety using the above-mentioned markers during the regular football season (~12 months). Assessments will be carried out at baseline, in the mid-season and after the season.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female football players

排除标准

  • age under 18

结局指标

主要结局

kidney function

时间窗: baseline and after the sport season (~12 months)

serum creatinine levels

次要结局

  • muscle damage(baseline and after the sport season (~12 months))
  • kidney function(baseline and after the sport season (~12 months))
  • hemogram(baseline and after the sport season (~12 months))

研究者

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

Bruno Gualano

Professor

University of Sao Paulo

研究点 (3)

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