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

NCT ID: NCT06923839

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-28
• Study Completion Date: 2026-04-30

Brief 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.

Conditions

Healthy Male Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo comparator that is identical to the active arm except for the absence of RUCILP

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo is identical to the active intervention except for the absence of the RUCILP molecule.

Active

Intervention is identical to the placebo arm except for the addition of RUCILP to the infusion.

Group Type: ACTIVE_COMPARATOR

Test bacterial peptide: RUCILP

Intervention Type: BIOLOGICAL

The naturally occuring gut peptide RUCILP synthesized by the commensal gut bacterium Ruminococcus torques

Interventions

Test bacterial peptide: RUCILP

The naturally occuring gut peptide RUCILP synthesized by the commensal gut bacterium Ruminococcus torques

Intervention Type: BIOLOGICAL

Placebo

Placebo is identical to the active intervention except for the absence of the RUCILP molecule.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oluf Pedersen

OTHER

Sponsor Role: lead

Responsible Party

Oluf Pedersen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Gentofte Hospital

Hellerup, , Denmark

Countries

Denmark

Other Identifiers

H-22011935

Identifier Type: -

Identifier Source: org_study_id