The Effects of a Ruminococcus Torques Strain Bacterium in Healthy Adults.

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Intervention Study to Explore Potential Metabolic Effects of Ruminococcus Torques Strain ATCC 27756 in Healthy Adults

Conditions
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Healthy, Overweight

Intervention / Treatment
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* Biological: Placebo
* Biological: Ruminococcus torques


Participation Criteria
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Eligibility Criteria
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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 Smoking 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A crossover study where subjects recieve placebo or Ruminococcus torques on two different study days with three to six weeks of wash-out between the study days.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The placebo will consist of solely glycerol-phosphate-buffered isotonic saline. | Biological: Placebo<br>* The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.<br>|
| Experimental: Ruminococcus torques<br>10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline | Biological: Ruminococcus torques<br>* 10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Matsuda Insulin Sensitivity Index | Differences in calculated Matsuda Insulin Sensitivity Index between the two study days | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ruminococcus Irisin-Like Peptide (RUCILP) | Differences in plasma RUCILP concentration between the two study days | During the six hours of the study day (up to six weeks between study days) | 
| Peptide YY | Differences in plasma Peptide YY concentration between the two study days | During the six hours of the study day (up to six weeks between study days) | 
| Glucose profile | Difference in blood glucose profile during the entirety of the study day | During the six hours of the study day (up to six weeks between study days) | 
| Resting energy expenditure | Difference in resting energy expenditure measured by indirect calorimetric | Three times during the study day for 15 minutes | 
| Activation of brown adipose tissue | Difference in temperature measured with thermographic camera of the collar bones | 15 minutes 3 times during each study day | 
| Bone dynamics | Differences in measures of biomarkers of bone turnover in blood | During the six hours of the study day (up to six weeks between study days) | 
| Gut microbiota | Changes in gut microbiota composition after each intervention | Samples taken prior to each visit (experimental days and follow-up visits) | 
| Metabolome | Changes is plasma metabolome after intervention | During the six hours of the study day (up to six weeks between study days) | 
| Area Under the Plasma Concentration Versus Time Curve of Gucagon-Like Peptide-1 | Differences in area under the curve between the two study days | During the six hours of the study day (up to six weeks between study days) | 
| Cytokine profile | Differences in the cytokine profiles during the study day | During the six hours of the study day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolism, Microbiota, Ruminococcus torques