Gentofte Hospital
Hellerup, 2900, Denmark
NCT Number: NCT05448274
A randomized, placebo controlled crossover study investigating the potential metabolic effects of the naturally occurring gut microbe Ruminococcus torques in healthy, overweight adults.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Hellerup, 2900, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.
10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Three times during the study day for 15 minutes
Difference in resting energy expenditure measured by indirect calorimetric
Time frame: 15 minutes 3 times during each study day
Difference in temperature measured with thermographic camera of the collar bones
Time frame: 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
Time frame: Samples taken prior to each visit (experimental days and follow-up visits)
Changes in gut microbiota composition after each intervention
Time frame: During the six hours of the study day (up to six weeks between study days)
Changes is plasma metabolome after intervention
Time frame: 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
Time frame: During the six hours of the study day
Differences in the cytokine profiles during the study day
Time frame: During the six hours of the study day (up to six weeks between study days)
Changes in heart rate during study day
Time frame: During the six hours of the study day (up to six weeks between study days)
Changes in blood pressure during study day
Time frame: 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
Time frame: 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
Time frame: 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
Oluf Pedersen
Other
An Intervention Study to Explore Potential Metabolic Effects of Ruminococcus Torques Strain ATCC 27756 in Healthy Adults
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