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临床试验/NCT03461068
NCT03461068已完成1 期

The Effect of Exogenous Ketone Monoester Supplement on Glycemic Response to an Oral Glucose Tolerance Test

University of British Columbia2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年3月26日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
15
试验地点
2
主要终点
Glucose area under the curve

研究概览

简要总结

The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to an oral glucose tolerance test in individuals with impaired fasting glucose.

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, Outcomes Assessor)

盲法说明

Placebo masked with flavouring and participants consume in opaque containers

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Not taking any medications affecting glucose metabolism.
  • Elevated fasting glucose level (5.6-6.9 mmol/L) OR body mass index >28 kg/m2 OR elevated waist circumference (>102 cm for males, >88 cm for females)

排除标准

  • Diagnosed with diabetes.
  • Diagnosed with heart disease.
  • Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
  • Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
  • Current consumption of ketone supplements
  • Pregnant or planning to become pregnant during the study (if female)

研究组 & 干预措施

Ketone monoester

Experimental

Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight)

干预措施: Ketone monoester (Dietary Supplement)

Placebo

Placebo Comparator

Acute morning dose of flavour-matched placebo.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Glucose area under the curve

时间窗: 2-hour

Area under the curve for glucose during oral glucose tolerance test

次要结局

  • Free fatty acids area under the curve(2-hour)
  • Insulin incremental area under the curve(2-hour)
  • Insulin area under the curve(2-hour)
  • Inflammatory cytokines(15 minutes)
  • C-peptide area under the curve(2-hour)
  • GLP-1 area under the curve(2-hour)
  • Glucagon area under the curve(2-hour)
  • Glucose incremental area under the curve(2-hour)
  • 2-hr glucose level(2-hour)
  • Caspase-1 activation(15 minutes)
  • Oral glucose sensitivity index(2-hour)

研究者

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

Jonathan Little

Assistant Professor

University of British Columbia

研究点 (2)

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