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

Primary Purpose

Overweight, Healthy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Placebo
Ruminococcus torques
Sponsored by
Oluf Pedersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight focused on measuring Metabolism, Microbiota, Ruminococcus torques

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ruminococcus torques

Arm Description

The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.

10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline

Outcomes

Primary Outcome Measures

Matsuda Insulin Sensitivity Index
Differences in calculated Matsuda Insulin Sensitivity Index between the two study days

Secondary Outcome Measures

Ruminococcus Irisin-Like Peptide (RUCILP)
Differences in plasma RUCILP concentration between the two study days
Peptide YY
Differences in plasma Peptide YY concentration between the two study days
Glucose profile
Difference in blood glucose profile during the entirety of the study day
Resting energy expenditure
Difference in resting energy expenditure measured by indirect calorimetric
Activation of brown adipose tissue
Difference in temperature measured with thermographic camera of the collar bones
Bone dynamics
Differences in measures of biomarkers of bone turnover in blood
Gut microbiota
Changes in gut microbiota composition after each intervention
Metabolome
Changes is plasma metabolome after intervention
Area Under the Plasma Concentration Versus Time Curve of Gucagon-Like Peptide-1
Differences in area under the curve between the two study days
Cytokine profile
Differences in the cytokine profiles during the study day

Full Information

First Posted
June 28, 2022
Last Updated
September 15, 2023
Sponsor
Oluf Pedersen
Collaborators
University of Copenhagen, Technical University of Denmark, University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT05448274
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
September 6, 2023 (Actual)
Study Completion Date
September 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Oluf Pedersen
Collaborators
University of Copenhagen, Technical University of Denmark, University Hospital, Gentofte, Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Healthy
Keywords
Metabolism, Microbiota, Ruminococcus torques

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded study where both the investigator (the physician), care provider (nurse) and the participants are blinded.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.
Arm Title
Ruminococcus torques
Arm Type
Experimental
Arm Description
10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.
Intervention Type
Biological
Intervention Name(s)
Ruminococcus torques
Intervention Description
10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline
Primary Outcome Measure Information:
Title
Matsuda Insulin Sensitivity Index
Description
Differences in calculated Matsuda Insulin Sensitivity Index between the two study days
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)
Secondary Outcome Measure Information:
Title
Ruminococcus Irisin-Like Peptide (RUCILP)
Description
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)
Title
Peptide YY
Description
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)
Title
Glucose profile
Description
Difference in blood glucose profile during the entirety of the study day
Time Frame
During the six hours of the study day (up to six weeks between study days)
Title
Resting energy expenditure
Description
Difference in resting energy expenditure measured by indirect calorimetric
Time Frame
Three times during the study day for 15 minutes
Title
Activation of brown adipose tissue
Description
Difference in temperature measured with thermographic camera of the collar bones
Time Frame
15 minutes 3 times during each study day
Title
Bone dynamics
Description
Differences in measures of biomarkers of bone turnover in blood
Time Frame
During the six hours of the study day (up to six weeks between study days)
Title
Gut microbiota
Description
Changes in gut microbiota composition after each intervention
Time Frame
Samples taken prior to each visit (experimental days and follow-up visits)
Title
Metabolome
Description
Changes is plasma metabolome after intervention
Time Frame
During the six hours of the study day (up to six weeks between study days)
Title
Area Under the Plasma Concentration Versus Time Curve of Gucagon-Like Peptide-1
Description
Differences in area under the curve between the two study days
Time Frame
During the six hours of the study day (up to six weeks between study days)
Title
Cytokine profile
Description
Differences in the cytokine profiles during the study day
Time Frame
During the six hours of the study day
Other Pre-specified Outcome Measures:
Title
Heart rate
Description
Changes in heart rate during study day
Time Frame
During the six hours of the study day (up to six weeks between study days)
Title
Blood pressure
Description
Changes in blood pressure during study day
Time Frame
During the six hours of the study day (up to six weeks between study days)
Title
Various hormones related to metabolism
Description
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)
Title
Standard hematologic blood samples
Description
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
Title
Standard clinical biochemical variables
Description
Differences in measurements of standard clinical biochemical biomarkers, such as alanine transaminase and creatinine
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oluf B Pedersen, Prof, MD
Organizational Affiliation
Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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