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临床试验/NCT04490226
NCT04490226已完成不适用

Impact of Endogenous vs. Exogenous Ketone Bodies on Appetite Control and Macronutrient Oxidation

University of Kiel2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
appetite control - GLP-1 concentration in plasma

研究概览

简要总结

Aim of the study is to compare the origin of ketone bodies: endogenous ketone bodies due to 36 hours fasting or 24 hours of ketogenic diet vs. exogenous ketone bodies as supplements additional to normal diet.

Secondary aim of the study is to validate the new metabolic chambers.

详细描述

Each study week starts with a 3-day run-in period with controlled diet at home and ends with a test-meal (breakfast) in the lab and following food record over the rest of the day at home.

  1. week: physical activity level (PAL) 1.3, 3 intervention days in the metabolic chamber: ad libitum energy intake, washout day, isocaloric diet, 36 hours fasting
  2. week: physical activity level (PAL) 1.3, 2 intervention days in the metabolic chamber: isocaloric diet, 36 hours fasting
  3. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: ad libitum energy intake, 36 hours fasting
  4. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: isocaloric diet, ketogenic diet (isocaloric)
  5. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: isocaloric diet, isocaloric diet + ketone body supplements (isocaloric)

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • BMI 19-29 kg/m2
  • low-medium habitual physical activity
  • women using hormonal contraceptive

排除标准

  • chronic illnesses
  • food allergies / intolerances
  • vegans and vegetarians
  • regular high physical activity (exercise >1 hour/d)
  • current weight loss diet / weight loss of >5 kg in the last 3 months
  • pregnant / lactating women
  • persons incapable of giving informed legal consent

结局指标

主要结局

appetite control - GLP-1 concentration in plasma

时间窗: 24 hours

Glucose Like Peptide-1 concentration in plasma (24 hour AUC)

appetite control - PYY concentration in plasma

时间窗: 24 hours

Peptide YY concentration in plasma (24 hour AUC)

appetite control - ghrelin

时间窗: 24 hours

ghrelin concentration in plasma (24 hour AUC)

appetite control - satiety quotient

时间窗: 30 min

satiety quotient of standard test-breakfast after 24 hours of intervention

appetite control - subjective feelings of hunger

时间窗: 24 hours

measured with visual analogue scales (24 hour AUC). The scale consists of a 10 cm vertical line anchored with "not hungry at all" at the left side and with "extremely hungry" at the right side.

次要结局

  • ß-Hydroxybutyrate concentration in serum(24 hours)
  • macronutrient oxidation(24 hours)
  • repeatability of energy expenditure measurements(24 hours)
  • energy expenditure(24 hours)
  • glycemia - glucose AUC(24 hours)

研究者

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

Prof. Dr. Dr. Anja Bosy-Westphal

Prof. Anja Bosy-Westphal, PhD, MD

University of Kiel

研究点 (2)

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