Impact of Endogenous vs. Exogenous Ketone Bodies on Appetite Control and Macronutrient Oxidation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 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.
- 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
- week: physical activity level (PAL) 1.3, 2 intervention days in the metabolic chamber: isocaloric diet, 36 hours fasting
- week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: ad libitum energy intake, 36 hours fasting
- week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: isocaloric diet, ketogenic diet (isocaloric)
- 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
- 是
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
研究组 & 干预措施
fasting, active
36 hours fasting, PAL 1.6
干预措施: Beta-Hydroxybutyrate as Ca-Mg-salt, active (Dietary Supplement)
fasting, active
36 hours fasting, PAL 1.6
干预措施: ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active (Dietary Supplement)
fasting, active
36 hours fasting, PAL 1.6
干预措施: fasting, inactive (Dietary Supplement)
fasting, active
36 hours fasting, PAL 1.6
干预措施: fasting, active (Dietary Supplement)
ketogenic diet, active
24 hours of ketogenic diet (liquid meals), PAL 1.6
干预措施: Beta-Hydroxybutyrate as Ca-Mg-salt, active (Dietary Supplement)
ketogenic diet, active
24 hours of ketogenic diet (liquid meals), PAL 1.6
干预措施: ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active (Dietary Supplement)
ketogenic diet, active
24 hours of ketogenic diet (liquid meals), PAL 1.6
干预措施: fasting, active (Dietary Supplement)
ketogenic diet, active
24 hours of ketogenic diet (liquid meals), PAL 1.6
干预措施: fasting, inactive (Dietary Supplement)
exogeneous ketone bodies, active
24 hours of ketone body supplements (Beta-Hydroxybutyrate as Ca-Mg-salt) additional to a normal diet (liquid meals), PAL 1.6
干预措施: Beta-Hydroxybutyrate as Ca-Mg-salt, active (Dietary Supplement)
exogeneous ketone bodies, active
24 hours of ketone body supplements (Beta-Hydroxybutyrate as Ca-Mg-salt) additional to a normal diet (liquid meals), PAL 1.6
干预措施: ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active (Dietary Supplement)
exogeneous ketone bodies, active
24 hours of ketone body supplements (Beta-Hydroxybutyrate as Ca-Mg-salt) additional to a normal diet (liquid meals), PAL 1.6
干预措施: fasting, active (Dietary Supplement)
exogeneous ketone bodies, active
24 hours of ketone body supplements (Beta-Hydroxybutyrate as Ca-Mg-salt) additional to a normal diet (liquid meals), PAL 1.6
干预措施: fasting, inactive (Dietary Supplement)
fasting, inactive
36 hours fasting, PAL 1.3
干预措施: Beta-Hydroxybutyrate as Ca-Mg-salt, active (Dietary Supplement)
fasting, inactive
36 hours fasting, PAL 1.3
干预措施: ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active (Dietary Supplement)
fasting, inactive
36 hours fasting, PAL 1.3
干预措施: fasting, active (Dietary Supplement)
fasting, inactive
36 hours fasting, PAL 1.3
干预措施: fasting, inactive (Dietary Supplement)
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
- macronutrient oxidation(24 hours)
- repeatability of energy expenditure measurements(24 hours)
- ß-Hydroxybutyrate concentration in serum(24 hours)
- energy expenditure(24 hours)
- glycemia - glucose AUC(24 hours)
研究者
Prof. Dr. Dr. Anja Bosy-Westphal
Prof. Anja Bosy-Westphal, PhD, MD
University of Kiel