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NCT Number: NCT06923839

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

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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Key information

Conditions

Healthy Male Adults

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test bacterial peptide: RUCILP

Biological

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

Placebo

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Plasma concentrations of insulin

    Time frame: During the 3 hours of RUCILP/placebo infusion

    Plasma measurements of insulin at different time points during the study day.

  2. Plasma concentrations of glucose

    Time frame: During the 3 hours of RUCILP/placebo infusion

    Plasma measurements of glucose at different time points during the study day.

  3. Plasma metabolome profile

    Time frame: During the 3 hours of RUCILP/placebo infusion

    Plasma metabolome profile at different time points during the study day.

  4. Plasma concentrations of RUCILP

    Time frame: During the 3 hours of RUCILP/placebo infusion

    Plasma measurements of RUCILP at different time points during the study day.

Other outcomes

  1. Blood leukocytes

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

    Concentration of leukocytes in blood

  2. Blood eosinophils

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

    Concentration of eosinophils in blood

  3. Total blood leukocytes

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

    Concentration of total leukocytes in blood

  4. Blood neutrophils

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

    Concentration of neutrophils in blood

  5. Blood platelets

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

    Concentration of platelets in blood

  6. Blood hemoglobin

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

    Concentration of hemoglobin in blood

  7. Plasma alanine transaminase (ALT)

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

    Concentration of alanine transaminase (ALT) in plasma

  8. Plasma aspartate transferase (AST)

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

    Concentration of aspartate transferase (AST) in plasma

  9. Plasma alkaline phosphatase

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

    Concentration of alkaline phosphatase in plasma

  10. Plasma albumin

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

    Concentration of albumin in plasma

  11. Plasma creatinine

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

    Concentration of creatinine in plasma

  12. Estimated Glomerular Filtration Rate (eGFR)

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

  13. Plasma sodium

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

    Concentration of sodium in plasma

  14. Plasma potassium

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

    Concentration of potassium in plasma

  15. Plasma calcium (total)

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

    Concentration of total calcium in plasma

  16. Plasma phosphate

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

    Concentration of phosphate in plasma

  17. Plasma creatine kinase

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

    Concentration of creatine kinase in plasma

  18. Plasma C-reactive protein

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

    Concentration of C-reactive protein in plasma

  19. Experienced adverse effects post infusion

    Time frame: At 180 minutes.

    Number of experienced adverse effects as noted in a diary at end of each study day.

  20. Experienced adverse effects during the four days following an infusion

    Time frame: During four days of follow-up after each study day.

    Number of experienced adverse effects as noted in a diary during four days of follow-up after each infusion.

Sponsors and collaborators

Lead sponsor

Oluf Pedersen

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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