Status:
ACTIVE_NOT_RECRUITING
Testing the Potential Metabolic Effect of the Human Gut Bacterial Peptide, RUCILP, in Healthy Men
Lead Sponsor:
Oluf Pedersen
Conditions:
Healthy Male Adults
Eligibility:
MALE
18-35 years
Phase:
PHASE1
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 polyp...
Eligibility Criteria
Inclusion
- Age between 18 and 35 years
- Self-reported good health
- Caucasian
- Normal body mass index (18.5 to \<25)
Exclusion
- 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
Key Trial Info
Start Date :
July 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06923839
Start Date
July 28 2025
End Date
April 1 2026
Last Update
October 3 2025
Active Locations (1)
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1
Gentofte Hospital
Hellerup, Denmark, 2900