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

NCT06923839 | Active Not Recruiting Phase 1

• 1 other identifier: H-22011935
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Plasma concentrations of insulin

  During the 3 hours of RUCILP/placebo infusion

• Plasma concentrations of glucose

  During the 3 hours of RUCILP/placebo infusion

• Plasma metabolome profile

  During the 3 hours of RUCILP/placebo infusion

• Plasma concentrations of RUCILP

  During the 3 hours of RUCILP/placebo infusion

Other Outcomes (20)

• Blood leukocytes

  At baseline, at 180 minutes, and at follow-up (4-8 days after study day)

• Blood eosinophils

  At baseline, at 180 minutes, and at follow-up (4-8 days after study day)

• Total blood leukocytes

  At baseline, at 180 minutes, and at follow-up (4-8 days after study day)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Active

ACTIVE COMPARATOR

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

Biological: Test bacterial peptide: RUCILP

Interventions

Test bacterial peptide: RUCILP BIOLOGICAL

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

Active

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 35 years
• Self-reported good health
• Caucasian
• Normal body mass index (18.5 to \<25)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oluf Pedersen: lead

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 11, 2025
• Study Start: July 28, 2025
• Primary Completion: August 27, 2025
• Study Completion: April 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)