Active — Not RecruitingPhase 1

Testing the Potential Metabolic Effect of the Human Gut Bacterial Peptide, RUCILP, in Healthy Men

Denmark15 participantsStarted 2025-07-28

Plain-language 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. 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.

Who can participate

Age range18 Years – 35 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 35 years * Self-reported good health * Caucasian * Normal body mass index (18.5 to \<25) 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 * Smoking * 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

What they're measuring

Plasma concentrations of GIP

Timeframe: During the 3 hours of RUCILP/placebo infusion

Plasma concentrations of GLP-1

Timeframe: During the 3 hours of RUCILP/placebo infusion

Plasma concentrations of PYY

Timeframe: During the 3 hours of RUCILP/placebo infusion

Trial details

NCT IDNCT06923839

SponsorOluf Pedersen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-27

View on ClinicalTrials.gov More Healthy Male Adults trials

Plain-language summary

Who can participate

Age range18 Years – 35 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.