Anabolic Potential of Adding 3-hydroxybutyrate (3-OHB) to Whey Protein in a Catabolic Inflammatory Disease Model: A Human Randomized Controlled Trial
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
- Change in forearm muscle kinetics measured by phenylalanine tracer (Netbalance, rate of disappearence and rate of apperance of phenylanine, nmol/100ml muscle/min)
研究概览
简要总结
This study aims to investigate the muscle anabolic potential of adding ketone (3-hydroxybutyrate) to whey protein compared with isocaloric, isonitrogenous whey protein in a human model of inflammatory catabolic disease. Further, this study aims to investigate whether the same amount of whey protein has different effects on muscles in an catabolic inflammatory setting compared with a healthy setting.
详细描述
Background: Muscle wasting during hospitalization is caused by a combination of immobilization (bed rest), hypocaloric diet and inflammation (e.g. sepsis), and preventive measures are needed. Whey protein is particularly potent in inducing muscle protein synthesis compared with other proteins, at least in healthy populations. Further, the ketone body 3-hydroxybutyrate (3-OHB) effectively preserved muscle in a model of acute inflammatory disease. However, little is known about whether 3-OHB can potentiate the effects of whey protein in a catabolic inflammatory setting.
Aim: This study aims to investigate the muscle anabolic potential of adding ketone (3-OHB) to whey protein compared with isocaloric, isonitrogenous whey protein in a human model of catabolic inflammatory disease. Further, this study aims to investigate whether the same amount of whey protein has different effects on muscles in an catabolic inflammatory setting compared with a healthy setting.
Hypothesis:
- 3-OHB potentiates the effect of whey protein in maintaining muscle mass in a catabolic inflammatory setting.
- The same amount of whey protein will have decreased muscle anabolic effects during catabolic inflammatory conditions compared with healthy conditions
Interventions:
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Between 20-40 years of age
- •Body mass index between 20-30 kg/m^2
- •Oral and written consent forms obtained prior to study day
排除标准
- •Recent immobilization of an extremity that is not fully rehabilitated
- •Lactose, lidocain or rubber allergies
- •Current disease
- •Use of anabolic steroids
- •Former major abdominal surgery (Or current problems with the GI tract)
- •>10 hours of exercise/weak
- •Present ketogenic diets or high-protein diets
- •Blood doner that does not want to discontinue blood donations until study completion
- •Pending MR scan
结局指标
主要结局
Change in forearm muscle kinetics measured by phenylalanine tracer (Netbalance, rate of disappearence and rate of apperance of phenylanine, nmol/100ml muscle/min)
时间窗: Change from baseline to 3.5 hours after intervention
Changes of forearm muscle phenylalanine kinetics from baseline to 3.5 hours after intervention using the forearm model
次要结局
- Change in concentration of total aminoacids(Change from baseline to 3.5 hours after intervention)
- Change in concentration of 3-hydroxybutyrate (mmol/L) )(Measured at baseline and every 30. min throughout the 3.5 hour sipping period)
- Change in glucose kinetics measured by glucose tracer (rate of apperance and rate of disappearance, mg/kg/min)(Change from baseline to 3.5 hours after intervention)
- Change in concentration of plasma insulin(Measured at baseline and every 30. min throughout the 3.5 hour sipping period)
- Change in concentration of plasma glucose(Measured at baseline and every 30. min throughout the 3.5 hour sipping period)
- Change in concentration of free fatty acids (FFA) levels(Change from baseline to 3.5 hours after intervention)
- Change in concentration of C-reactive peptide (CRP)(Change from baseline to 3.5 hours after intervention)
- Change in concentration of blood leucocytes (x10^9/L)(Change from baseline to 3.5 hours after intervention)
- Change in concentration of stress hormones (glucagon, cortisol, adrenalin, noradrenalin)(Change from baseline to 3.5 hours after intervention)
- Difference in concentration of free fatty acids (FFA) (healthy vs catabolic)(Measured at the end of the 3.5 hour basal period.)
- Change in intracellular muscle signalling(Change from baseline to 3.5 hours after intervention)
- Difference in muscle forearm kinetics measured by phenylalanine tracer (Netbalance, rate of apperance, rate og disappearance) (healthy vs catabolic)(measured at the end of the 3.5 hour basal period)
- Difference in concentration of total amino acids (healthy vs catabolic)(measured at the end of the 3.5 hour basal period)
- Difference in glucose kinetics measured with glucose tracer (mg/kg/min) (healthy vs catabolic)(measured at the end of the 3.5 hour basal period)
- Difference in concentration of C-reactive peptide (CRP) (healthy vs catabolic)(Measured at the end of the 3.5 hour basal period.)
- Difference in concentration of leucocytes (healthy vs catabolic)(Measured at the end of the 3.5 hour basal period.)
- Difference in intracellular muscle signalling (healthy vs catabolic)(Measured at the end of the 3.5 hour basal period.)
- Difference in concentration of 3-hydroxybutyrate (mmol/L) (healthy vs catabolic)(Measured at the end of the 3.5 hour basal period.)
- Difference in concentration of hormones (insulin, glucagon, cortisol, growth hormone, adrenaline, noradrenalin) (healthy vs catabolic)(Measured at the end of the 3.5 hour basal period.)
- Difference in whole body protein metabolism (healthy vs catabolic)(Measured at the end of the 3.5 hour basal period.)
- Difference in concentration of cytokines (healthy vs catabolic)(Measured at baseline and 120 and 240 minutes after LPS administration)
- Difference in axillary temperature (healthy vs catabolic)(Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration)
- Difference in heart rate (healthy vs catabolic)(Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration)
- Difference in mean arterial pressure (MAP) (healthy vs catabolic)(Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration)
- Difference in symptom score (healthy vs catabolic)(Measured at baseline and 1, 2, 3, 4, 5, 6 and 7 hours after LPS administration)