Clinical trial NCT06923839: Testing the Potential Metabolic Effect of the Human Gut Bacterial Peptide, RUCILP, in Healthy Men
Official title: Testing the Potential Metabolic Effect of the Human Gut Bacterial Peptide, RUCILP, in Healthy Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Male Adults
Keywords: Metabolism
Duodenal infusion
Postbiotics
Gut bacterial peptide
Intervention study
Intestinal infusion
Ruminococcus torques
Plasma glucose
Plasma insulin
Plasma PYY
Plasma incretins
Plasma GIP
Plasma RUCILP
Plasma GLP-1
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.


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

Primary outcomes:
measure: Plasma concentrations of GIP
timeFrame: During the 3 hours of RUCILP/placebo infusion
measure: Plasma concentrations of GLP-1
timeFrame: During the 3 hours of RUCILP/placebo infusion
measure: Plasma concentrations of PYY
timeFrame: During the 3 hours of RUCILP/placebo infusion
Secondary outcomes:
measure: Plasma concentrations of insulin
timeFrame: During the 3 hours of RUCILP/placebo infusion
measure: Plasma concentrations of glucose
timeFrame: During the 3 hours of RUCILP/placebo infusion
measure: Plasma metabolome profile
timeFrame: During the 3 hours of RUCILP/placebo infusion
measure: Plasma concentrations of RUCILP
timeFrame: During the 3 hours of RUCILP/placebo infusion
Other outcomes:
measure: Blood leukocytes
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Blood eosinophils
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Total blood leukocytes
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Blood neutrophils
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Blood platelets
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Blood hemoglobin
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Plasma alanine transaminase (ALT)
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Plasma aspartate transferase (AST)
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Plasma alkaline phosphatase
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Plasma albumin
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Plasma creatinine
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Plasma sodium
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Plasma potassium
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Plasma calcium (total)
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Plasma phosphate
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Plasma creatine kinase
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Plasma C-reactive protein
timeFrame: At baseline, at 180 minutes, and at follow-up (4-8 days after study day)
measure: Experienced adverse effects post infusion
timeFrame: At 180 minutes.
measure: Experienced adverse effects during the four days following an infusion
timeFrame: During four days of follow-up after each study day.
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
References: