Exploring the metabolic effects of a gut bacterial peptide in healthy men
Testing the Potential Metabolic Effect of the Human Gut Bacterial Peptide, RUCILP, in Healthy Men
This study is testing whether a gut bacterial peptide called RUCILP can affect hormone levels and blood sugar in healthy young men.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Male |
| Sponsor | University Hospital, Gentofte, Copenhagen Academic / other |
| Locations | 1 site (Hellerup) |
| Trial ID | NCT06923839 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the metabolic effects of RUCILP, a gut bacterial peptide, in healthy male adults aged 18 to 35. The study employs a randomized, double-blinded, placebo-controlled, cross-over design, where participants will receive either RUCILP or a placebo via duodenal infusion. The primary focus is to assess the peptide's impact on plasma concentrations of hormones such as GLP-1, GIP, and PYY, as well as glucose and insulin levels. The trial aims to build on preclinical findings that suggest RUCILP may lower blood glucose and influence insulin release.
Who should consider this trial
Good fit: Ideal candidates are healthy Caucasian males aged 18 to 35 with a normal body mass index.
Not a fit: Patients with known metabolic disorders, gastrointestinal symptoms, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into metabolic regulation and potential treatments for metabolic disorders.
How similar studies have performed: While preclinical studies have shown promising results with RUCILP, this specific approach in healthy humans is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hellerup
- Gentofte Hospital — Hellerup, Denmark (Recruiting)
Study contacts
- Study coordinator: Oluf B Pedersen, Professor
- Email: oluf@sund.ku.dk
- Phone: +4529382526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.