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

An Intervention Study to Explore Potential Metabolic Effects of Ruminococcus Torques Strain ATCC 27756 in Healthy Adults

A randomized, placebo controlled crossover study investigating the potential metabolic effects of the naturally occurring gut microbe Ruminococcus torques in healthy, overweight adults.

Study Overview

• Status: Completed
• Conditions: Healthy; Overweight
• Intervention / Treatment: Biological: Placebo; Biological: Ruminococcus torques

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.	Biological: Placebo; The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.
Experimental: Ruminococcus torques; 10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline	Biological: Ruminococcus torques; 10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
Peptide YY	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)
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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Oluf Pedersen
• Collaborators: University of Copenhagen; University Hospital, Gentofte, Copenhagen; Technical University of Denmark
• Investigators: Principal Investigator: Oluf B Pedersen, Prof, MD, Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Actual): September 6, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Microbiota; Metabolism; Ruminococcus torques
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: H-21075670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No