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

Not Applicable

Completed

• Conditions: Healthy; Overweight
• Interventions: Biological: Ruminococcus torques; Biological: Placebo

• Registration Number: NCT05448274
• Lead Sponsor: Oluf Pedersen

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.

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-07-02
• Study First Posted: 2022-07-07
• Study Start: 2023-05-03
• Status Verified: 2023-09
• Primary Completion: 2023-09-06
• Study Completion: 2023-09-14
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ruminococcus torques	Ruminococcus torques	10\^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline
Placebo	Placebo	The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Gentofte Hospital; 🇩🇰 Hellerup, Denmark