Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMax Nieuwdorp
About this trial
The goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight.
The investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.
Eligibility criteria
Qualifiers
Increased waist circumference (>102 cm men, 88>cm women)
Insulin resistance (HOMA>2.5)
18-70 years
Disqualifiers
Use of systemic medication (except for paracetamol), including antibiotics and pro-/prebiotics in the past three months or during the study period.
A history of a cardiovascular event
A history of cholecystectomy
Overt untreated gastrointestinal disease or abnormal bowel habits
Trial design
Treatments tested in this trial
- D piger
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Max Nieuwdorp
Lead sponsor
Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)
Sponsor institution
Source ClinicalTrials.gov