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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Technical University of Denmark | OTHER |
| University Hospital, Gentofte, Copenhagen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo will consist of solely glycerol-phosphate-buffered isotonic saline. |
|
| Ruminococcus torques | Experimental | 10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | The placebo will consist of solely glycerol-phosphate-buffered isotonic saline. |
|
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Changes in heart rate during study day | During the six hours of the study day (up to six weeks between study days) |
| Blood pressure | Changes in blood pressure during study day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oluf B Pedersen, Prof, MD | Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte Hospital | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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.
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Double blinded study where both the investigator (the physician), care provider (nurse) and the participants are blinded.
| Ruminococcus torques | Biological | 10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline |
|
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 |
| During the six hours of the study day (up to six weeks between study days) |
| Various hormones related to metabolism | Differences in measures of various hormones during the study day | During the six hours of the study day (up to six weeks between study days) |
| Standard hematologic blood samples | Differences in measures of standard hematologic biomarkers in the blood, such as platelets | During the six hours of the study day (up to six weeks between study days) as well as one week after each study day |
| Standard clinical biochemical variables | Differences in measurements of standard clinical biochemical biomarkers, such as alanine transaminase and creatinine | During the six hours of the study day (up to six weeks between study days) as well as one week after each study day |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |