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 range

18 Years – 35 Years

Sex

MALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 35 Years

Sex

MALE

See this in plain English?

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