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临床试验/NCT06746805
NCT06746805招募中不适用

The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise Performed With High Rates of Carbohydrate Ingestion in Trained Cyclists

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2024年3月4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
27
试验地点
2
主要终点
Exogenous carbohydrate oxidation rate

研究概览

简要总结

The purpose of this study is to examine the effect of exogenous ketone body supplementation on carbohydrate metabolism during exercise. In a randomized, crossover, and double-blind study, 20 endurance trained adult males and females aged 18-50 years, will ingest carbohydrates with either a ketone monoester supplement before and throughout a 3-hour exercise session or carbohydrates with a flavour-matched ketone-free placebo. The main aim of this study is to compare the exogenous carbohydrate oxidation rates during exercise between the ketone monoester and placebo conditions.

研究设计

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

盲法说明

Color and flavor matched placebo

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-50 years of age
  • Trained cyclist/triathlete (VO2peak > 55 ml/kg/min for males and >48 ml/mg/min for females)
  • Healthy as per medical history and investigator's/physician's judgement
  • Having given written informed consent

排除标准

  • Use of medication that could impact study outcomes and/or interfere with the expected mechanism of action of ketone supplements (e.g. Chronic use of gastric acid suppressing medication, statins, corticosteroids)
  • Diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes (e.g. Diabetes mellitus)
  • Diagnosed musculoskeletal disorders
  • Adhering to a carbohydrate restrictive diet
  • Participation in another study at the same time
  • Blood donation in the 2 months before the first experimental trial
  • Plasma donation in the 2 weeks before the first experimental trial
  • Males: VO2peak <55 ml/min/kg body mass
  • Females: VO2peak <48 ml/min/kg body mass
  • Females: pregnancy

结局指标

主要结局

Exogenous carbohydrate oxidation rate

时间窗: Acute:during 3 hours of exercise

Exogenous carbohydrate oxidation rate during exercise measured by 13C enrichment in breath. CHO+KETONE vs CHO+PLACEBO condition

次要结局

  • Endogenous carbohydrate disappearance rate(Acute:during 3 hours of exercise)
  • Exogenous carbohydrate disappearance rate(Acute:during 3 hours of exercise)
  • Total carbohydrate disappearance rate(Acute:during 3 hours of exercise)
  • Exogenous carbohydrate appearance rate(Acute:during 3 hours of exercise)
  • Endogenous carbohydrate appearance rate(Acute:during 3 hours of exercise)
  • Total carbohydrate appearance rate(Acute:during 3 hours of exercise)
  • Plasma glucose enrichments during exercise(Acute:during 3 hours of exercise)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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