An Intervention Study to Explore Potential Metabolic Effects of Ruminococcus Torques Strain ATCC 27756 in Healthy Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Matsuda Insulin Sensitivity Index
Study Overview
Brief Summary
A randomized, placebo controlled crossover study investigating the potential metabolic effects of the naturally occurring gut microbe Ruminococcus torques in healthy, overweight adults.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double blinded study where both the investigator (the physician), care provider (nurse) and the participants are blinded.
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between 18 and 40 years
- •Self-reported good health
- •Caucasian
- •Body Mass Index > 27 kg/m^2
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Matsuda Insulin Sensitivity Index
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
Oluf Pedersen
Professor, MD
University Hospital, Gentofte, Copenhagen