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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
D piger
Dietary supplementProbiotic d piger
Placebo
Dietary supplementPlacebo
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: D pigerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gut engraftment
the number of reads of d piger in feces using q pcr
Time frame
30 days2
adverse events
the number of adverse events in both groups
Time frame
30 days3
Renal function
Number of participants with a decreased kidney function, defined as a rise in serum creatinine of \>26,5 micromol/L in 48 h
Time frame
30 days4
Occurence of anemia
Number of patients with Hb \< 8,5 mmol/L
Time frame
30 daysSecondary outcomes
1
Fructose in peripheral blood
Area under the curve of fructose in peripheral blood upon ingestion of 1 gram / kg unlabeled fructose in combination with 1000mg of D-fructose-13C6
Time frame
30 days2
Fructose metabolites in breath
Area under the curve of various metabolites (e.g. ethanol) will be measured in breath samples upon ingestion of 1 gram / kg unlabeled fructose in combination with 1000mg of D-fructose-13C6
Time frame
30 days3
Time-in-range
Increase in Time-in-range (TIR,%), a parameter of continuous glucose monitoring devices, where TIR can be between 0 and 100%. A higher TIR reflects a better outcome.
Time frame
30 days4
Continuous glucose monitoring
Decrease in glucose variability (GV, %), a parameter of continuous glucose monitoring devices, where GV can be between 0 and 100%. A lower GV reflects a better outcome.
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Max Nieuwdorp
Lead sponsor
Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)
Sponsor institution
Source ClinicalTrials.gov