An Intervention Study to Explore Potential Metabolic Effects of Ruminococcus Torques Strain ATCC 27756 in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Matsuda Insulin Sensitivity Index
研究概览
简要总结
A randomized, placebo controlled crossover study investigating the potential metabolic effects of the naturally occurring gut microbe Ruminococcus torques in healthy, overweight adults.
详细描述
By analyzing blood samples, indirect calorimetric as well as thermographic assessment of clavicular temperature we want to investigate whether or not the commensal gut bacterium Ruminococcus toqrues strain ATCC 27756 has any metabolic effects in healthy adults. The subjects will recieve the intervention with the live bacterium given through a duodenal feeding tube. The trial is double blinded and placebo controlled using a crossover design. Subjects will be given an intervention with either placebo or Ruminococcus on two different study days with up to six weeks of wash-out between each study day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded study where both the investigator (the physician), care provider (nurse) and the participants are blinded.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 40 years
- •Self-reported good health
- •Caucasian
- •Body Mass Index > 27 kg/m^2
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
- •Pregnancy - ongoing or planned
- •Alcohol or drug abuse
- •Use of creatine as dietary supplement during study period
- •Plasma creatinine above the normal range (>105 μmol/L for men and >90 μmol/L for women)
- •Known significant liver disease or plasma alanine transaminase concentration ≥ 3 × normal value
- •Values for hemoglobin, leukocytes, or thrombocytes outside of the normal ranges
结局指标
主要结局
Matsuda Insulin Sensitivity Index
时间窗: During two hours following a standard glucose solution (75g glucose in 250 ml of water) after the second dose of Ruminococcus or placebo has been given during the study day (second measurement up to six weeks later)
Differences in calculated Matsuda Insulin Sensitivity Index between the two study days
次要结局
- Peptide YY(During the six hours of the study day (up to six weeks between study days))
- Ruminococcus Irisin-Like Peptide (RUCILP)(During the six hours of the study day (up to six weeks between study days))
- Bone dynamics(During the six hours of the study day (up to six weeks between study days))
- Gut microbiota(Samples taken prior to each visit (experimental days and follow-up visits))
- Metabolome(During the six hours of the study day (up to six weeks between study days))
- Glucose profile(During the six hours of the study day (up to six weeks between study days))
- Resting energy expenditure(Three times during the study day for 15 minutes)
- Activation of brown adipose tissue(15 minutes 3 times during each study day)
- Area Under the Plasma Concentration Versus Time Curve of Gucagon-Like Peptide-1(During the six hours of the study day (up to six weeks between study days))
- Cytokine profile(During the six hours of the study day)
研究者
Oluf Pedersen
Professor, MD
University Hospital, Gentofte, Copenhagen