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临床试验/NCT06547307
NCT06547307招募中不适用

Effects of Caffeine, CYP1A2 and ADORA2A Genotypes on Cycling Endurance Performance.

Masaryk University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Efficacy of caffeine to improve endurance performance (time to complete 10 km trial)

研究概览

简要总结

The aim of this randomized, double-blind, placebo-controlled experiment will be to assess the potential effect of the selected gene polymorphism (CYP1A2, ADORA2A) on performance after caffeine ingestion.

详细描述

This randomized, double-blinded, placebo-controlled, within-subjects counter-measured study design will include 60 males and females that fall between the given age range (18-35 years).

Participants will complete five visits (~90-120 min each, 2 visits during the first week,3 visit during week 2-4) in the Laboratory at Faculty of Sports Studies of Masaryk University. All testing will take place Monday to Friday during morning hours (7-12) to minimize potential diurnal effect on sports performance. Participants will be instructed to maintain their regular diet (pre-testing meals will be replicated for all visits) and sleeping habits, avoid strenuous activity 48 hours before each visit, and abstain from caffeine one week prior to the first visit and for the duration of the data collection (4 weeks).

Sample size calculations We estimated sample size using G*Power 3.1 (Version 3.1.9.4). Effect size = 0.25, the trial would be powered to detect small but still physiologically important effect.

Alpha error = 0.025 Power (1-Beta probability) = 0.8 Number of groups = 6 - number of stratification required for genotype subgroup analysis number of measurements = 3 Sample size = based on calculation, 60 participants are required

Recruitment

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy person
  • any training status
  • within age limits
  • without contraindications to perform the test on a bicycle trainer
  • No contraindications to caffeine intake

排除标准

  • Pregnancy
  • Breast feeding
  • Cardiovascular disease
  • Hypertension
  • Liver disease in the previous two months
  • Taking drugs that can affect liver function
  • Illness in the period of 14 days before the start of the research
  • Use of caffeine during research

结局指标

主要结局

Efficacy of caffeine to improve endurance performance (time to complete 10 km trial)

时间窗: 2 Hours

To determine if caffeine intake improves endurance performance compared to placebo. Efficacy of caffeine doses (2 mg/kg and 4 mg/kg) to shorten the time needed to complete the 10 km time trial.

次要结局

  • Caffeine ingestion and genotype interaction(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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