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临床试验/NCT07065864
NCT07065864已完成不适用

Ketone Body Administration Impact on Work Capacity and Physiologic Reserve at Altitude

Florida Institute for Human and Machine Cognition1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2023年8月4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
17
试验地点
1
主要终点
Evaluate submaximal exercise performance

研究概览

简要总结

The primary purpose of the study was to investigate effects of an orally administered ketone ester drink on endurance exercise performance during acute extreme hypoxia. Drinking this ketone supplement increases energy substrates known as ketone bodies in the blood, which may also act as metabolic signaling molecules. The ketone drink used in this study is recognized by the FDA as generally regarded as safe (GRAS). Some reports suggest that high ketone levels may enhance one's ability to tolerate hypoxia.

详细描述

High altitude environments limit oxygen availability in circulation and working tissues, leading to a decreased physiological reserve during physical exertion. Acute hypoxia elevates heart rate during submaximal work in a compensatory attempt, but decreases maximal heart rate progressively with increasing hypoxia. This contributes to a reduction in aerobic power (i.e. maximal rate of oxygen uptake, VO2max) an average of 6.3% per 1000m of elevation. Consumption of exogenous ketone bodies has been shown to enhance oxygen availability at rest at simulated altitudes up to 6100m, associated with better cognitive performance.

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
Single (Participant)

盲法说明

Participants are blinded to ketone or placebo consumption.

入排标准

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

入选标准

  • •Healthy adult males 18 years of age or older (females are excluded because the 7th SFG consists only of males)
  • •Able to provide informed consent
  • •Able to perform the prescribed exercise and all study assessments
  • •Proficiency with the English language (reading, writing, speaking)

排除标准

  • •Any health or medical condition (e.g., cardiovascular, respiratory, musculoskeletal, neurologic) that would preclude exercise testing or potentially influence exercise performance, as determined by health and medical history questionnaire.
  • •Any condition that would preclude an accurate DXA body composition scan (e.g. joint replacement).

研究组 & 干预措施

Ketone

Experimental

Ketone consumption prior to 24 minute submaximal bicycle ride at simulated 4500 meter altitude.

干预措施: Ketone ester (Dietary Supplement)

Placebo

Placebo Comparator

steady state submaximal exercise (6 minutes each at 40, 50, and 60% of the peak power achieved at VO2max) at simulated 4500m after consuming the ketone ester or placebo

干预措施: Placebo (Other)

结局指标

主要结局

Evaluate submaximal exercise performance

时间窗: 6.5 hours time commitment

Evaluate submaximal exercise performance and physiologic reserve in hypoxia after consuming the ketone ester or placebo drink. Submaximal steady state VO2 relative to VO2max is the primary dependent variable. High altitude environments limit oxygen availability in circulation and working tissues, leading to a decreased physiological reserve during physical exertion. This contributes to a reduction in aerobic power (i.e. maximal rate of oxygen uptake, VO2max) an average of 6.3% per 1000m of elevation. Consumption of exogenous ketone bodies has been shown to enhance oxygen availability at rest at simulated altitudes up to 6100m, associated with better cognitive performance.

次要结局

  • Evaluate physiologic reserve in hypoxia(6.5 hours time commitment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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