Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
- Conditions
- ObesitySteatosis of LiverMetabolic Syndrome
- Interventions
- Dietary Supplement: D pigerDietary Supplement: Placebo
- Registration Number
- NCT06502834
- Lead Sponsor
- Max Nieuwdorp
- Brief Summary
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.
- Detailed Description
The investigators perform a randomized, placebo controlled trial in 2x10 participants.
The participants will be given placebo or d piger as an oral suspension once daily for 30 days.
At baseline and after 30 days, a fructose challenge test with fomepizole, gastroduodenoscopy and MRI liver + FibroScan will be performed. Patient will attend the clinical trial unit weekly for safety visits.
The participants will be overweight males or females age 18-70 with impaired glucose tolerance.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
- 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
- Liver enzymes>2.5 fold higher than the upper limit of normal range
- Smoking
- Alcohol abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description D piger D piger D. piger vial with 109 colony forming units (CFU) (=108 CFU D. piger per ml in 10ml of glycerol 10% and 10% maltrodextrin). Placebo Placebo Placebo vial (10ml of glycerol 10% and 10% maltrodextrin)
- Primary Outcome Measures
Name Time Method Occurence of anemia 30 days Number of patients with Hb \< 8,5 mmol/L
Changes in leucocytes 30 days Number of patients with leucocytes \<4,0 or \>10,5 x10E9 cells/L
Changes in aspartate aminotransferase (AST) 30 days Number of patients with AST \> 43 IU/L
adverse events 30 days the number of adverse events in both groups
Changes in alanine aminotransferase (ALT) 30 days Number of patients with ALT \> 45 IU/L
Changes in total bilirubin 30 days Number of patients with total bilirubin \> 24 micromol/L
Gut engraftment 30 days the number of reads of d piger in feces using q pcr
Renal function 30 days Number of participants with a decreased kidney function, defined as a rise in serum creatinine of \>26,5 micromol/L in 48 h
Changes in alkaline phosphatase (ALP) 30 days Number of patients with ALP \> 126 IU/L
Changes in Gamma-glutamyltransferase (GGT) 30 days Number of patients with GGT \> 117 IU/L
Changes in thrombocytes 30 days Number of patients with thrombocytes \<150 x 10E9 cells/
- Secondary Outcome Measures
Name Time Method Fructose in peripheral blood 30 days 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
Dietary intake 30 days Participants are asked to fill out an online dietary questionnaire for the 3 days prior to study visit 2,3,4,5 and 7
Time-in-range 30 days 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.
Continuous glucose monitoring 30 days 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.
Bioreactor analyses 30 days Using specific anaerobic culturing, ethanol production of fecal samples will be assessed of bacterial strains.
Fructose metabolites in breath 30 days 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
Glycemic control 30 days Changes in fasting glucose (mmol/L)
Intestinal microbiota composition 30 days Changes from baseline of relative abundance (%) of bacterial phyla, genera and species between groups and within participants.
MRI 30 days Liver fat measured by proton density fat fraction (PDFF) MRI liver
FibroScan 30 days Liver stiffness measured by FibroScan
Fructose metabolites in urine 30 days Using 24h urine, the investigators will measure fecal concentrations of fructose metabolites such as ethanol, as well as SCFAs and bile acids.
Questionnaires 30 days Changes in Gastro-intestinal Quality of Life Index (GIQLI score) (points). The minimum and maximum score are 31 and 155 points respectively, and a higher score reflects a better outcome.
Fructose metabolites in feces 30 days Using 24h feces, the investigators will measure fecal concentrations of fructose metabolites such as ethanol, as well as short chain fatty acids (SCFAs) and bile acids.
Trial Locations
- Locations (1)
Amsterdam UMC location AMC
🇳🇱Amsterdam, Netherlands