Clinical trial NCT05448274: The Effects of a Ruminococcus Torques Strain Bacterium in Healthy Adults.
Official title: An Intervention Study to Explore Potential Metabolic Effects of Ruminococcus Torques Strain ATCC 27756 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Healthy
Keywords: Metabolism
Microbiota
Ruminococcus torques
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Technical University of Denmark
name: University Hospital, Gentofte, Copenhagen
First posted: 2022-07-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Matsuda Insulin Sensitivity Index
timeFrame: 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 outcomes:
measure: Ruminococcus Irisin-Like Peptide (RUCILP)
timeFrame: During the six hours of the study day (up to six weeks between study days)
measure: Peptide YY
timeFrame: During the six hours of the study day (up to six weeks between study days)
measure: Glucose profile
timeFrame: During the six hours of the study day (up to six weeks between study days)
measure: Resting energy expenditure
timeFrame: Three times during the study day for 15 minutes
measure: Activation of brown adipose tissue
timeFrame: 15 minutes 3 times during each study day
measure: Bone dynamics
timeFrame: During the six hours of the study day (up to six weeks between study days)
measure: Gut microbiota
timeFrame: Samples taken prior to each visit (experimental days and follow-up visits)
measure: Metabolome
timeFrame: During the six hours of the study day (up to six weeks between study days)
measure: Area Under the Plasma Concentration Versus Time Curve of Gucagon-Like Peptide-1
timeFrame: During the six hours of the study day (up to six weeks between study days)
measure: Cytokine profile
timeFrame: During the six hours of the study day
Other outcomes:
measure: Heart rate
timeFrame: During the six hours of the study day (up to six weeks between study days)
measure: Blood pressure
timeFrame: During the six hours of the study day (up to six weeks between study days)
measure: Various hormones related to metabolism
timeFrame: During the six hours of the study day (up to six weeks between study days)
measure: Standard hematologic blood samples
timeFrame: During the six hours of the study day (up to six weeks between study days) as well as one week after each study day
measure: Standard clinical biochemical variables
timeFrame: During the six hours of the study day (up to six weeks between study days) as well as one week after each study day
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Gentofte Hospital
name: Oluf B Pedersen, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References: