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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo comparator that is identical to the active arm except for the absence of RUCILP |
|
| Active | Active Comparator | Intervention is identical to the placebo arm except for the addition of RUCILP to the infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test bacterial peptide: RUCILP | Biological | The naturally occuring gut peptide RUCILP synthesized by the commensal gut bacterium Ruminococcus torques |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of GIP | Plasma measurements of GIP at different time points during the study day. | 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. | During the 3 hours of RUCILP/placebo infusion |
| Plasma concentrations of PYY | Plasma measurements of PYY at different time points during the study day. | During the 3 hours of RUCILP/placebo infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of insulin | Plasma measurements of insulin at different time points during the study day. | During the 3 hours of RUCILP/placebo infusion |
| Plasma concentrations of glucose |
| Measure | Description | Time Frame |
|---|---|---|
| Blood leukocytes | Concentration of leukocytes in blood | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Blood eosinophils | Concentration of eosinophils in blood |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte Hospital | Hellerup | 2900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42177350 | Derived | 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 May 23. doi: 10.1007/s00125-026-06751-0. Online ahead of print. |
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Due to GDPR regulations we are unable to share IPD with other researchers.
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| Placebo | Other | Placebo is identical to the active intervention except for the absence of the RUCILP molecule. |
|
Plasma measurements of glucose at different time points during the study day.
| During the 3 hours of RUCILP/placebo infusion |
| Plasma metabolome profile | Plasma metabolome profile at different time points during the study day. | During the 3 hours of RUCILP/placebo infusion |
| Plasma concentrations of RUCILP | Plasma measurements of RUCILP at different time points during the study day. | During the 3 hours of RUCILP/placebo infusion |
| At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Total blood leukocytes | Concentration of total leukocytes in blood | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Blood neutrophils | Concentration of neutrophils in blood | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Blood platelets | Concentration of platelets in blood | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Blood hemoglobin | Concentration of hemoglobin in blood | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Plasma alanine transaminase (ALT) | Concentration of alanine transaminase (ALT) in plasma | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Plasma aspartate transferase (AST) | Concentration of aspartate transferase (AST) in plasma | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Plasma alkaline phosphatase | Concentration of alkaline phosphatase in plasma | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Plasma albumin | Concentration of albumin in plasma | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Plasma creatinine | Concentration of creatinine in plasma | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Estimated Glomerular Filtration Rate (eGFR) | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Plasma sodium | Concentration of sodium in plasma | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Plasma potassium | Concentration of potassium in plasma | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Plasma calcium (total) | Concentration of total calcium in plasma | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Plasma phosphate | Concentration of phosphate in plasma | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Plasma creatine kinase | Concentration of creatine kinase in plasma | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Plasma C-reactive protein | Concentration of C-reactive protein in plasma | At baseline, at 180 minutes, and at follow-up (4-8 days after study day) |
| Experienced adverse effects post infusion | Number of experienced adverse effects as noted in a diary at end of each study day. | At 180 minutes. |
| Experienced adverse effects during the four days following an infusion | Number of experienced adverse effects as noted in a diary during four days of follow-up after each infusion. | During four days of follow-up after each study day. |