Testing the Potential Metabolic Effect of the Human Gut Bacterial Peptide, RUCILP, in Healthy Men
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Plasma concentrations of GIP
研究概览
简要总结
The goal of this randomized, double-blinded and placebo-controlled clinical cross-over trial is in healthy men to explore the potential metabolic effects of the naturally occurring gut bacterial polypeptide, RUCILP. This bacterial peptide is produced by commensal strains of Ruminococcus torques in the human gut microbiota.
In preclinical studies of rodents, RUCILP lowers blood glucose and stimulates release of plasma insulin, glucagon-like peptide-1(GLP-1) and Peptide YY (PYY) but induces a decline of glucose-dependent insulinotropic polypeptide (GIP).
In the present trial, the investigators want to explore potential effects of intraduodenally delivered RUCILP on release of plasma concentrations of GLP-1, GIP and PYY.
In addition, the investigators will test for potential effects of intestinal RUCILP infusion on plasma concentrations of glucose, insulin and metabolome.
Participants will have a duodenal tube placed into which RUCILP or placebo will be infused over 3 hours after an initial standardized liquid meal infusion into the duodenal tube.
Participants will on different days and in a randomized order receive either placebo or RUCILP infusion into the tube.
Safety is acutely monitored under the intervention and postintervention safety is monitored by clinical biochemistry measures of hematology, and liver and kidney functions. The study participants will further keep a diary of any experienced adverse effects during the week after the intervention.
Primary OUTCOMES: a composite of changes in plasma concentrations of GLP-1, GIP and PYY.
Secondary OUTCOMES: changes in plasma glucose, plasma insulin and plasma metabolome profile.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 35 years
- •Self-reported good health
- •Caucasian
- •Normal body mass index (18.5 to <25)
排除标准
- •Any known disorder/disease that could interfere with study results or is seen as compromising to the study (as assessed by the investigator), for example diabetes, cancer or cardiovascular or kidney disease.
- •Use of any daily medication as well as p.r.n. (pro re nata; not taken regularly) medication that cannot be discontinued during the trial
- •Use of antibiotics during the recent three months
- •Acute or chronic gastrointestinal symptoms
- •Lactose intolerance
- •Alcohol or drug abuse
- •Use of creatine as dietary supplement during study period
- •Plasma creatinine concentration above the normal range (>105 μmol/L)
- •Known significant liver disease or plasma ALAT concentration ≥ 3 × normal value
- •Values for hemoglobin, leukocytes, or thrombocytes outside of the normal ranges
研究组 & 干预措施
Placebo
Placebo comparator that is identical to the active arm except for the absence of RUCILP
干预措施: Placebo (Other)
结局指标
主要结局
Plasma concentrations of GIP
时间窗: During the 3 hours of RUCILP/placebo infusion
Plasma measurements of GIP at different time points during the study day.
Plasma concentrations of GLP-1
时间窗: During the 3 hours of RUCILP/placebo infusion
Plasma measurements of GLP-1 at different time points during the study day.
Plasma concentrations of PYY
时间窗: During the 3 hours of RUCILP/placebo infusion
Plasma measurements of PYY at different time points during the study day.
次要结局
- Plasma concentrations of insulin(During the 3 hours of RUCILP/placebo infusion)
- Plasma concentrations of glucose(During the 3 hours of RUCILP/placebo infusion)
- Plasma metabolome profile(During the 3 hours of RUCILP/placebo infusion)
- Plasma concentrations of RUCILP(During the 3 hours of RUCILP/placebo infusion)
研究者
Oluf Pedersen
Professor
University Hospital, Gentofte, Copenhagen