Markers of Appetite Regulation During Exogenous Ketosis - a Placebo Controlled Randomized Study of Appetite Regulatory and Metabolic Markers After Intake of a Keto- or Glucogenic Drink.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- GLP-1 concentration
研究概览
简要总结
The aim of this study is to investigate the relationship, if any, between markers of satiety, desire to eat, hunger, and metabolic markers of the regulation hereof during ketosis as compared with a Glucose-containing and a Placebo drink adjusted for taste.
详细描述
All subjects are, in random order, tested on three separate occasions with intake of weight adjusted and taste matched drink of i) a ketone ester, and ii) an isocaloric and -volumetric glucose drink, or iii) an isovolumetric tap water drink.
Subjects are studied for five hours with baseline and blood sampling on multiple occasions. A satiety questionaire are included.
Subjects are recruited through notice on website for this purpose. Sample size calculations were performed prior to inclusion (n=10). According to protocolized statistical plan, missing data will not be replaced and no imputation will occur. Data will be analyzed by applying a repeated measurements multilevel model with intervention, time and their interactions as categorical factors. Effects size are adjusted for small sample size.
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
All subjects are, in random order, tested on three separate occasions with intake of weight adjusted and taste matched drink of i) a ketone ester (HVMN Ketone, 38 Mason St, 3rd Floor, San Francisco, CA 94102, USA) and ii) an isocaloric and -volumetric glucose drink, or iii) an isovolumetric tap water drink. Taste matching for the latter two are done by adding of a bitterness additive (Bitrex, Integriertes Trademarketing GmbH Herderstraße 16, 23564 Lübeck, Germany) with additional adding Stevia (Bodylab Stevia Drops; Bodylab,Plastvænget 3D, 9650 Hadsund, Denmark) for the tap water drink. Subjects will subsequently drink 50 mL of zero-calorie drink (Gatorade (Gatorade Company, Inc., Chicago, IL, USA) in order to eliminate any remaining flavour of the intervention drinks.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 18-65 years
- •BMI 20-35 kg/m2
- •Expected ease of catheter insertion
- •Oral and written informed consent
排除标准
- •Inability to fully understand the consent including consent forms
- •Inability to cooperate to the trial
- •Any electrolyte disorders, kidney disease or otherwise compromised renal function including excess risk hereof, e.g. hypertension, albuminuria, autoimmune disease, family history of kidney disease
- •Any liver or bile disease including excess risk hereof, e.g. hepatotoxic drugs, alcohol abuse disorder, gallstones, pancreatitis, autoimmune disease, family history of liver disease
- •Diabetes mellitus or any metabolic and/or hormonal disease including diagnosed/undiagnosed reactive hypoglycemia or similar disorders. This includes treatment with drugs, dietary supplement with inference on key metabolic or hormonal markers, e.g. insulin, glukagon, lipids, and GLP-1
- •Any use of illegal or otherwise use of medicinal products without prescription
- •Anemia or other know disease of the hematopoietic system
- •Previous bariatric surgery
- •Previous myocardial infarction or uncontrolled myocardial ischemia
- •Recent intended/unintended weight loss
- •Allergies to catheters or adhesives
结局指标
主要结局
GLP-1 concentration
时间窗: 5 hours
Development of GLP-1 concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Acyl ghrelin concentration
时间窗: 5 hours
Development of acyl ghrelin concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
次要结局
- Satiety, desire to eat, and perceived hunger sensation(5 hours)
- Insulin concentration(5 hours)
- Glucose concentration(5 hours)
- Free fatty acids concentration(5 hours)