OverweightNCT05448274
The Effects of a Ruminococcus Torques Strain Bacterium in Healthy Adults.
A study testing Ruminococcus torques in people with Overweight and Healthy, run by Oluf Pedersen at 1 site in Denmark.
Trial summary
A randomized, placebo controlled crossover study investigating the potential metabolic effects of the naturally occurring gut microbe Ruminococcus torques in healthy, overweight adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Healthy
- What is being tested?
- Ruminococcus torques
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 3 May 2023to 14 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 years
- Self-reported good health
- Caucasian
- Body Mass Index > 27 kg/m^2
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight, Healthy
- Being tested
- Placebo, Ruminococcus torques
- Keywords
- Metabolism, Microbiota, Ruminococcus torques
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
The placebo will consist of solely glycerol-phosphate-buffered isotonic saline.
Ruminococcus torquesBiological
10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo will consist of solely glycerol-phosphate-buffered isotonic saline. Receives: Biological: Placebo |
| Ruminococcus torques | Experimental | 10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline Receives: Biological: Ruminococcus torques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matsuda Insulin Sensitivity Index
Differences in calculated Matsuda Insulin Sensitivity Index between the two study days
Measured: 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 (10)
Ruminococcus Irisin-Like Peptide (RUCILP)
Differences in plasma RUCILP concentration between the two study days
Measured: 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
Measured: 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
Measured: During the six hours of the study day (up to six weeks between study days)
Resting energy expenditure
Difference in resting energy expenditure measured by indirect calorimetric
Measured: 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
Measured: 15 minutes 3 times during each study day
Bone dynamics
Differences in measures of biomarkers of bone turnover in blood
Measured: 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
Measured: Samples taken prior to each visit (experimental days and follow-up visits)
Metabolome
Changes is plasma metabolome after intervention
Measured: 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
Measured: 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
Measured: During the six hours of the study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start3 May 2023
- Primary completion6 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oluf Pedersen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Technical University of Denmark, University Hospital, Gentofte, Copenhagen
- Responsible party
- Sponsor-investigator, Oluf Pedersen, University Hospital, Gentofte, Copenhagen
- Investigators
- Oluf B Pedersen, Prof, MD, Principal investigator, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448274
- Sponsor's protocol ID
- H-21075670
- Status last verified
- Sep 2023
- First submitted
- 28 Jun 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaede J, Fan Y, Lyu L, Stankevic E, Gasbjerg LS, Rossing P, Oresic M, Hyotylainen T, Brix S, Lund AB, Olsen DA, Petersen ERB, Brandslund I, Hartmann B, Holst JJ, Knop FK, Pedersen O. A short-term randomized clinical trial testing feasibility of and physiological responses to a Ruminococcus torques strain in healthy overweight humans. Genome Med. 2026 Jul 16. doi: 10.1186/s13073-026-01708-9. Online ahead of print.
PubMed 42464306
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Study to Explore Potential Metabolic Effects of Ruminococcus Torques Strain ATCC 27756 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05448274
- Acronym / sponsor ID
- H-21075670
- Conditions
- Overweight, Healthy
- Keywords
- Metabolism, Microbiota, Ruminococcus torques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Oluf PedersenUniversity, hospital or other
- Collaborators
- University of Copenhagen, Technical University of Denmark, University Hospital, Gentofte, Copenhagen
- Study start
- 3 May 2023 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboThe placebo will consist of solely glycerol-phosphate-buffered isotonic saline. |
| Ruminococcus torques | Experimental | Biological: Ruminococcus torques10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 40 years
- Self-reported good health
- Caucasian
- Body Mass Index > 27 kg/m^2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe placebo will consist of solely glycerol-phosphate-buffered isotonic saline. | Biological | Placebo |
| Ruminococcus torques10^11 live bacterial cells in glycerol-phosphate-buffered isotonic saline | Biological | Ruminococcus torques |
Primary outcome
Matsuda Insulin Sensitivity Index
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
10 secondary outcomes
Ruminococcus Irisin-Like Peptide (RUCILP)
Time frame: During the six hours of the study day (up to six weeks between study days)
Peptide YY
Time frame: During the six hours of the study day (up to six weeks between study days)
Glucose profile
Time frame: During the six hours of the study day (up to six weeks between study days)
Resting energy expenditure
Time frame: Three times during the study day for 15 minutes
Activation of brown adipose tissue
Time frame: 15 minutes 3 times during each study day
Bone dynamics
Time frame: During the six hours of the study day (up to six weeks between study days)
Gut microbiota
Time frame: Samples taken prior to each visit (experimental days and follow-up visits)
Metabolome
Time frame: 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
Time frame: During the six hours of the study day (up to six weeks between study days)
Cytokine profile
Time frame: During the six hours of the study day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 42464306Gaede J, Fan Y, Lyu L, Stankevic E, Gasbjerg LS, Rossing P, Oresic M, Hyotylainen T, Brix S, Lund AB, Olsen DA, Petersen ERB, Brandslund I, Hartmann B, Holst JJ, Knop FK, Pedersen O. A short-term randomized clinical trial testing feasibility of and physiological responses to a Ruminococcus torques strain in healthy overweight humans. Genome Med. 2026 Jul 16. doi: 10.1186/s13073-026-01708-9. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oluf B Pedersen, Prof, MD principal investigator
Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ruminococcus torques in people with Overweight and Healthy, run by Oluf Pedersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matsuda Insulin Sensitivity Index (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05448274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.