Healthy Male AdultsPhase 1NCT06923839
Testing the Potential Metabolic Effect of the Human Gut Bacterial Peptide, RUCILP, in Healthy Men
A Phase 1 study testing Test bacterial peptide: RUCILP in people with Healthy Male Adults, run by Oluf Pedersen at 1 site in Denmark.
Trial summary
The goal of this randomized, double-blinded and placebo-controlled clinical cross-over trial is in healthy men to explore the potential metabolic effects of the naturally occurring gut bacterial polypeptide, RUCILP. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Adults
- What is being tested?
- Test bacterial peptide: RUCILP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Jul 2025to 4 Sep 2025
- Phase
- Phase 1
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 35 years
- Self-reported good health
- Caucasian
- Normal body mass index (18.5 to <25)
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
- Smoking
Show all 11Show fewer
- Alcohol or drug abuse
- Use of creatine as dietary supplement during study period
- Plasma creatinine concentration above the normal range (>105 μmol/L)
- Known significant liver disease or plasma ALAT 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
The goal of this randomized, double-blinded and placebo-controlled clinical cross-over trial is in healthy men to explore the potential metabolic effects of the naturally occurring gut bacterial polypeptide, RUCILP. This bacterial peptide is produced by commensal strains of Ruminococcus torques in the human gut microbiota.
In preclinical studies of rodents, RUCILP lowers blood glucose and stimulates release of plasma insulin, glucagon-like peptide-1(GLP-1) and Peptide YY (PYY) but induces a decline of glucose-dependent insulinotropic polypeptide (GIP).
Read more
In the present trial, the investigators want to explore potential effects of intraduodenally delivered RUCILP on release of plasma concentrations of GLP-1, GIP and PYY.
In addition, the investigators will test for potential effects of intestinal RUCILP infusion on plasma concentrations of glucose, insulin and metabolome.
Participants will have a duodenal tube placed into which RUCILP or placebo will be infused over 3 hours after an initial standardized liquid meal infusion into the duodenal tube.
Participants will on different days and in a randomized order receive either placebo or RUCILP infusion into the tube.
Safety is acutely monitored under the intervention and postintervention safety is monitored by clinical biochemistry measures of hematology, and liver and kidney functions. The study participants will further keep a diary of any experienced adverse effects during the week after the intervention.
Primary OUTCOMES: a composite of changes in plasma concentrations of GLP-1, GIP and PYY.
Secondary OUTCOMES: changes in plasma glucose, plasma insulin and plasma metabolome profile.
- Conditions
- Healthy Male Adults
- Being tested
- Test bacterial peptide: RUCILP, Placebo
- Keywords
- Metabolism, Duodenal infusion, Postbiotics, Gut bacterial peptide, Intervention study, Intestinal infusion, Ruminococcus torques, Plasma glucose, Plasma insulin, Plasma PYY, Plasma incretins, Plasma GIP, Plasma RUCILP, Plasma GLP-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test bacterial peptide: RUCILPBiological
The naturally occuring gut peptide RUCILP synthesized by the commensal gut bacterium Ruminococcus torques
PlaceboOther
Placebo is identical to the active intervention except for the absence of the RUCILP molecule.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo comparator that is identical to the active arm except for the absence of RUCILP Receives: Other: Placebo |
| Active | Active comparator | Intervention is identical to the placebo arm except for the addition of RUCILP to the infusion. Receives: Biological: Test bacterial peptide: RUCILP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of GIP
Plasma measurements of GIP at different time points during the study day.
Measured: During the 3 hours of RUCILP/placebo infusion
Plasma concentrations of GLP-1
Plasma measurements of GLP-1 at different time points during the study day.
Measured: During the 3 hours of RUCILP/placebo infusion
Plasma concentrations of PYY
Plasma measurements of PYY at different time points during the study day.
Measured: During the 3 hours of RUCILP/placebo infusion
Secondary outcomes (4)
Plasma concentrations of insulin
Plasma measurements of insulin at different time points during the study day.
Measured: During the 3 hours of RUCILP/placebo infusion
Plasma concentrations of glucose
Plasma measurements of glucose at different time points during the study day.
Measured: During the 3 hours of RUCILP/placebo infusion
Plasma metabolome profile
Plasma metabolome profile at different time points during the study day.
Measured: During the 3 hours of RUCILP/placebo infusion
Plasma concentrations of RUCILP
Plasma measurements of RUCILP at different time points during the study day.
Measured: During the 3 hours of RUCILP/placebo infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start28 Jul 2025
- Primary completion27 Aug 2025
- Study completion4 Sep 2025
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 Healthy Male AdultsStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oluf Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oluf Pedersen, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923839
- Sponsor's protocol ID
- H-22011935
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to GDPR regulations we are unable to share IPD with other researchers.
Publications
Gaede J, Fan Y, Lyu L, Gasbjerg LS, Rossing P, Hartmann B, Holst JJ, Lund AB, Knop FK, Pedersen O. A randomised clinical trial testing the safety of and metabolic responses to short-term duodenal infusion of recombinant RORDEP1 in healthy men. Diabetologia. 2026 Aug;69(8):2338-2346. doi: 10.1007/s00125-026-06751-0. Epub 2026 May 23.
PubMed 42177350
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Potential Metabolic Effect of the Human Gut Bacterial Peptide, RUCILP, in Healthy Men
- ClinicalTrials.gov ID
- NCT06923839
- Acronym / sponsor ID
- H-22011935
- Conditions
- Healthy Male Adults
- Keywords
- Metabolism, Duodenal infusion, Postbiotics, Gut bacterial peptide, Intervention study, Intestinal infusion, Ruminococcus torques, Plasma glucose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Oluf PedersenUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 11 Apr 2025 (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.
The goal of this randomized, double-blinded and placebo-controlled clinical cross-over trial is in healthy men to explore the potential metabolic effects of the naturally occurring gut bacterial polypeptide, RUCILP. This bacterial peptide is produced by commensal strains of Ruminococcus torques in the human gut microbiota.
In preclinical studies of rodents, RUCILP lowers blood glucose and stimulates release of plasma insulin, glucagon-like peptide-1(GLP-1) and Peptide YY (PYY) but induces a decline of glucose-dependent insulinotropic polypeptide (GIP).
In the present trial, the investigators want to explore potential effects of intraduodenally delivered RUCILP on release of plasma concentrations of GLP-1, GIP and PYY.
In addition, the investigators will test for potential effects of intestinal RUCILP infusion on plasma concentrations of glucose, insulin and metabolome.
Participants will have a duodenal tube placed into which RUCILP or placebo will be infused over 3 hours after an initial standardized liquid meal infusion into the duodenal tube.
Participants will on different days and in a randomized order receive either placebo or RUCILP infusion into the tube.
Safety is acutely monitored under the intervention and postintervention safety is monitored by clinical biochemistry measures of hematology, and liver and kidney functions. The study participants will further keep a diary of any experienced adverse effects during the week after the intervention.
Primary OUTCOMES: a composite of changes in plasma concentrations of GLP-1, GIP and PYY.
Secondary OUTCOMES: changes in plasma glucose, plasma insulin and plasma metabolome profile.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo comparator that is identical to the active arm except for the absence of RUCILP |
| Active | Active comparator | Biological: Test bacterial peptide: RUCILPIntervention is identical to the placebo arm except for the addition of RUCILP to the infusion. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 35 years
- Self-reported good health
- Caucasian
- Normal body mass index (18.5 to <25)
Key exclusion criteria (11 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 |
|---|---|---|
| Test bacterial peptide: RUCILPThe naturally occuring gut peptide RUCILP synthesized by the commensal gut bacterium Ruminococcus torques | Biological | Active |
| PlaceboPlacebo is identical to the active intervention except for the absence of the RUCILP molecule. | Other | Placebo |
Primary outcome
Plasma concentrations of GIP
Time frame: During the 3 hours of RUCILP/placebo infusion
Plasma measurements of GIP at different time points during the study day.
Plasma concentrations of GLP-1
Time frame: During the 3 hours of RUCILP/placebo infusion
Plasma measurements of GLP-1 at different time points during the study day.
Plasma concentrations of PYY
Time frame: During the 3 hours of RUCILP/placebo infusion
Plasma measurements of PYY at different time points during the study day.
4 secondary outcomes
Plasma concentrations of insulin
Time frame: During the 3 hours of RUCILP/placebo infusion
Plasma concentrations of glucose
Time frame: During the 3 hours of RUCILP/placebo infusion
Plasma metabolome profile
Time frame: During the 3 hours of RUCILP/placebo infusion
Plasma concentrations of RUCILP
Time frame: During the 3 hours of RUCILP/placebo infusion
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 29 Sep 2026.
- Derived from this study: PubMed 42177350Gaede J, Fan Y, Lyu L, Gasbjerg LS, Rossing P, Hartmann B, Holst JJ, Lund AB, Knop FK, Pedersen O. A randomised clinical trial testing the safety of and metabolic responses to short-term duodenal infusion of recombinant RORDEP1 in healthy men. Diabetologia. 2026 Aug;69(8):2338-2346. doi: 10.1007/s00125-026-06751-0. Epub 2026 May 23.
- Individual participant dataSharing planned: No. Due to GDPR regulations we are unable to share IPD with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test bacterial peptide: RUCILP in people with Healthy Male Adults, 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 11 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 29 Sep 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasma concentrations of GIP (time frame: During the 3 hours of RUCILP/placebo infusion). The study lists 3 primary outcomes in all. 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 NCT06923839, 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 29 Sep 2026.