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临床试验/NCT04579770
NCT04579770已完成不适用

Effect of Oral Ketone and Sodium Bicarbonate Administration on Physiological and Metabolic Parameters During Endurance Exercise in Hypoxia

Jozef Stefan Institute1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
1
主要终点
Change in Cycling performance - Simulated Sprint

研究概览

简要总结

This study is investigating the effects of oral ketone and sodium bicarbonate administration on physiological and metabolic parameters during cycling endurance exercise in hypoxia. Ketone body supplementation is commonly used among elite endurance athletes that also compete in the hypoxia (at altitude). To-date effects of ketones have only been investigated in normoxia and the data in hypoxia is lacking. Hence, we want to investigate the effect of oral ketone ester intake with and without additional sodium bicarbonate (NaHCO3) ingestion on i) blood-acid base balance and ii) exercise performance during prolonged exercise under hypoxic conditions. Information obtained via this study should provide valuable information with regard to optimisation of exercise training and athletic performance, and more importantly, provide pioneering insight on the metabolic and physiological responses to ketosis under hypoxic conditions.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Males between 18 and 35 years old
  • Recreational or competitive cyclist performing regularly cycling training sessions of at least 4 hours, with an average training volume of more than 6 hours per week
  • Good health status confirmed by a medical screening
  • VO2max higher than 55 ml.min-1.kg-1
  • Body Mass Index (BMI) between 18 and 25

排除标准

  • Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise
  • Intake of any medication or nutritional supplement that is known to affect exercise performance
  • Intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study.
  • Blood donation within 3 months prior to the start of the study
  • More than 3 alcoholic beverages per day, including a maximum of one glass of wine per day
  • Involvement in elite athletic training at a semi-professional or professional level
  • Current participation in another research trial
  • Any other argument to believe that the subject is unlikely to successfully complete the full study protocol

结局指标

主要结局

Change in Cycling performance - Simulated Sprint

时间窗: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions

Time to exhaustion at 175% of the intensity of the second lactate threshold

Change in Cycling performance - Simulated 15-min long time trial

时间窗: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions

Performance (average power output) during the 15 min long time trial on an ergometer

Change in Blood acid-base balance (pH and [HCO3-]) during cycling

时间窗: 5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions

Blood acid-base balance assement

次要结局

  • Change in Blood ketone concentrations during exercise(5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions)
  • Change in Respiratory parameters (VE, V̇O2 and V̇CO2) during exercise(5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions)
  • Change in muscle oxygenation during exercise(5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions)
  • Change in Blood glucose concentrations during exercise(5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions)
  • Change in Blood lactate concentrations during exercise(5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions)
  • Change in arterial oxygen saturation during exercise(5 hours - this is how long each experimental session is going to last. Subjects would be asked to do it 3 times as there are 3 different experimental conditions)

研究者

发起方
Jozef Stefan Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tadej Debevec

Principal Investigator

Jozef Stefan Institute

研究点 (1)

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