Testing the Potential Metabolic Effect of the Human Gut Bacterial Peptide, RUCILP, in Healthy Men
Launched by OLUF PEDERSEN · Apr 4, 2025
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a substance called RUCILP, which is a natural peptide produced by certain bacteria in our gut. The researchers aim to understand how RUCILP might affect metabolism in healthy men, particularly how it influences the levels of certain hormones that help regulate blood sugar and appetite. Participants will receive either RUCILP or a placebo (a substance with no active ingredients) through a tube placed in their intestine, and this will happen after they have a standardized meal. The trial will monitor various health measures to ensure safety and track any side effects.
To be eligible for this study, participants must be healthy men aged 18 to 35 years, of Caucasian descent, and have a normal body weight. Those with certain health conditions, such as diabetes or kidney disease, and individuals taking specific medications or supplements are not allowed to participate. Throughout the trial, participants will be closely observed to ensure their well-being, and they will keep a diary to report any side effects they may experience. This study is an exciting opportunity to learn more about the potential benefits of gut bacteria on our metabolism!
Gender
MALE
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
About Oluf Pedersen
Oluf Pedersen is a distinguished clinical trial sponsor recognized for its commitment to advancing medical research and innovation. With a robust portfolio of clinical trials, the organization focuses on developing novel therapeutics and enhancing treatment protocols across various therapeutic areas. Leveraging a collaborative approach, Oluf Pedersen works closely with leading researchers, healthcare professionals, and regulatory bodies to ensure the highest standards of scientific integrity and patient safety. The sponsor is dedicated to translating research findings into meaningful clinical applications, ultimately aiming to improve patient outcomes and contribute to the broader field of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hellerup, , Denmark
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported