Echocardiographic Changes After Oral Intake of 3-hydroxy Butyrate+Whey in a Human Endotoxemia Model
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 left ventricular outflow tract velocity time integral
研究概览
简要总结
This study evaluates the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during human endotoxemia. Further, this study compares cardiovascular changes during healthy and catabolic conditions.
Participants will receive isocaloric, isonitrogenous beverages of either whey or 3-OHB+whey in a randomized crossover design during either healthy (overnight fast) or catabolic conditions (inflammation/endotoxemia + 36 h fast and bed rest).
详细描述
Background: A newly published study found beneficial cardiovascular effects of 3-OHB infusion in a population with chronic heart failure, significantly increasing cardiac output. Similar effects on cardiac output were observed in healthy volunteers. These findings pave the way for 3-OHB as a therapeutic nutritional supplement, since it is well-absorbed during oral consumption. However, it is unknown whether the cardiovascular effects of 3-OHB persist during a sepsis-like catabolic state and when administered orally.
Aim: This study aims to investigate the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during a human disease model, comprising endotoxemia + bed rest + fast.
Hypothesis:
- Adding the ketone body 3-OHB to an oral protein supplement increases cardiac output measures
- Catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces cardiovascular changes compared with healthy conditions (overnight fast)
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
- Double (Participant, Outcomes Assessor)
盲法说明
Interventions (saline/LPS) or whey/3-OHB+whey will be given by the investigator, and the echocardiography will be performed by another blinded investigator.
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 left ventricular outflow tract velocity time integral
时间窗: Measured during the basal period and after 1.5 hours of intervention
Echocardiographic changes in left ventricular outflow tract velocity time integral from the basal period and after 1.5 hours of intervention
次要结局
- Changes in Left Ventricular Ejection Fraction (LVEF)(Measured during the basal period and after 1.5 hours of intervention)
- Changes in Global Longitudinal Strain (GLS)(Measured during the basal period and after 1.5 hours of intervention)
- Changes in heart rate(Measured during the basal period and after 1.5 hours of intervention)
- Changes in S´ Max(Measured during the basal period and after 1.5 hours of intervention)
- Changes in blood pressure(Measured during the basal period and after 1.5 hours of intervention)
- Changes in axillary temperature(Measured during the basal period and after 1.5 hours of intervention)
- Difference in Left Ventricular Ejection Fraction (LVEF) (Healthy vs catabolic conditions)(Measured after 2 hours of basal period)
- Difference in S´ Max (Healthy vs catabolic conditions)(Measured after 2 hours of basal period)
- Difference in Global Longitudinal Strain (GLS) (Healthy vs catabolic conditions)(Measured after 2 hours of basal period)
- Difference in axillary temperature (healthy vs catabolic)(Measured after 2 hours of basal period)
- Difference in blood pressure (healthy vs catabolic)(Measured after 2 hours of basal period)
- Difference in heart rate (healthy vs catabolic)(Measured after 2 hours of basal period)