Gastro-intestinal and Hormonal Responses to Systemic Inflammatory Disease: A Human Model Comprising Endotoxemia, Fast and Bed Rest.
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
- Difference in total gastro-intestinal transit time (healthy vs catabolic conditions)
研究概览
简要总结
The aim of this study is to describe hormonal responses and changes of the gastrointestinal (GI) tract during healthy and catabolic inflammatory 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: Endotoxemia (LPS) is known to cause fever, inflammation and nausea, but the underlying mechanisms are unknown. In a human disease model comprising LPS-induced inflammation, 36 hour fast and bed rest the investigators want to investigate mechanisms accounting for the nausea and decreased food intake often observed in hospitalized patients.
Aim: This study aims to investigate total transit time and motility of the GI-tract together with the regulation of gut- and appetite hormones following catabolic conditions compared with healthy controlled conditions
Hypothesis:
Catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces GI-tract and hormonal 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
- Single (Outcomes Assessor)
盲法说明
Outcome Assessor will be blinded for all interventions and will recieve raw data sequentially numbered, and will therefore not know which data are from the same test object and which intervention was given.
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
- •Smoking 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
Difference in total gastro-intestinal transit time (healthy vs catabolic conditions)
时间窗: Measured from intake of the Smartpill (together with the bolus of the protein beverages at t=210) until excretion with faeces (expected time frame: 2-5 days))
Difference in total gastro-intestinal transit time measured by the Smartpill system between healthy and catabolic conditions. A pooled mean of the catabolic conditions will be used, if there is no difference between first and second exposure to LPS or "catabolic + whey" and "catabolic + 3-OHB/whey" interventions.
次要结局
- Difference in gastric emptying (healthy vs catabolic conditions)(Measured from intake of the Smartpill (t = 210) until it leaves the ventricle (assessed by rise in pH levels, expected time frame: 2-7 hours))
- Difference in colon passage time (healthy vs catabolic conditions)(Measured from the timepoint where Smartpill leaves the small intestine until it is excreted with faeces (assessed by specific predefined motility and pH patterns, expected timeframe 1-3 days))
- Difference in GI motility (healthy vs catabolic conditions)(Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days))
- Difference in The Pain Catastrophizing Scale (PCS) (healthy vs catabolic conditions)(Given at timepoint t = 240 minutes)
- Difference in body temperature (healthy vs catabolic conditions)(Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days))
- Difference in small intestine passage time (healthy vs catabolic conditions)(Measured from the timepoint where Smartpill leaves the ventricle until it enters the colon (assessed by specific predefined motility and pH patterns, expected timeframe 1-3 days))
- Difference in gastric- and appetite hormones (GLP-1, GIP, PYY and ghrelin) (healthy vs catabolic conditions)(Measured at baseline and 30, 60, 90, 120 and 200 minutes after the beginning of the basal period)
- Difference in The Gastrointestinal Symptom Rating Scale (GSRS) (healthy vs catabolic conditions)(Given at timepoint t = 240 minutes)
- Difference in pH in the ventricle, small intestine and colon (healthy vs catabolic conditions)(Measured from intake of the Smartpill (t = 210) until excretion with faeces (expected time frame: 2-5 days))