Testing the Potential Metabolic Effect of the Human Gut Bacterial Peptide, RUCILP, in Healthy Men

Oluf Pedersen

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Male Adults

Treatments: Other: Placebo; Biological: Test bacterial peptide: RUCILP

Study type: Interventional

Funder types: Other

Identifiers

NCT06923839

H-22011935

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo comparator that is identical to the active arm except for the absence of RUCILP

Treatment:

Other: Placebo

Active

Active Comparator group

Description:

Intervention is identical to the placebo arm except for the addition of RUCILP to the infusion.

Treatment:

Biological: Test bacterial peptide: RUCILP