Healthy, Overweight
Conditions
Keywords
Metabolism, Microbiota, Ruminococcus torques
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.
Interventions
BIOLOGICALPlacebo
The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.
BIOLOGICALRuminococcus torques
10\^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline
Sponsors
University of Copenhagen
Technical University of Denmark
University Hospital, Gentofte, Copenhagen
Oluf Pedersen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded study where both the investigator (the physician), care provider (nurse) and the participants are blinded.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Matsuda Insulin Sensitivity Index | 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
| Measure | Time frame | Description |
|---|---|---|
| Ruminococcus Irisin-Like Peptide (RUCILP) | During the six hours of the study day (up to six weeks between study days) | Differences in plasma RUCILP concentration between the two study days |
| Bone dynamics | During the six hours of the study day (up to six weeks between study days) | Differences in measures of biomarkers of bone turnover in blood |
| Gut microbiota | Samples taken prior to each visit (experimental days and follow-up visits) | Changes in gut microbiota composition after each intervention |
| Metabolome | During the six hours of the study day (up to six weeks between study days) | Changes is plasma metabolome after intervention |
| 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) | Differences in area under the curve between the two study days |
| Cytokine profile | During the six hours of the study day | Differences in the cytokine profiles during the study day |
| Peptide YY | During the six hours of the study day (up to six weeks between study days) | Differences in plasma Peptide YY concentration between the two study days |
| Glucose profile | During the six hours of the study day (up to six weeks between study days) | Difference in blood glucose profile during the entirety of the study day |
| Resting energy expenditure | Three times during the study day for 15 minutes | Difference in resting energy expenditure measured by indirect calorimetric |
| Activation of brown adipose tissue | 15 minutes 3 times during each study day | Difference in temperature measured with thermographic camera of the collar bones |
Other
| Measure | Time frame | Description |
|---|---|---|
| Various hormones related to metabolism | During the six hours of the study day (up to six weeks between study days) | Differences in measures of various hormones during the study day |
| Standard hematologic blood samples | During the six hours of the study day (up to six weeks between study days) as well as one week after each study day | Differences in measures of standard hematologic biomarkers in the blood, such as platelets |
| Standard clinical biochemical variables | During the six hours of the study day (up to six weeks between study days) as well as one week after each study day | Differences in measurements of standard clinical biochemical biomarkers, such as alanine transaminase and creatinine |
| Blood pressure | During the six hours of the study day (up to six weeks between study days) | Changes in blood pressure during study day |
| Heart rate | During the six hours of the study day (up to six weeks between study days) | Changes in heart rate during study day |
Countries
Denmark
Outcome results
None listed