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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Amsterdam UMC location AMC
Amsterdam, Netherlands
RECRUITINGGut engraftment
the number of reads of d piger in feces using q pcr
Time frame: 30 days
adverse events
the number of adverse events in both groups
Time frame: 30 days
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 days
Occurence of anemia
Number of patients with Hb \< 8,5 mmol/L
Time frame: 30 days
Changes in leucocytes
Number of patients with leucocytes \<4,0 or \>10,5 x10E9 cells/L
Time frame: 30 days
Changes in thrombocytes
Number of patients with thrombocytes \<150 x 10E9 cells/
Time frame: 30 days
Changes in aspartate aminotransferase (AST)
Number of patients with AST \> 43 IU/L
Time frame: 30 days
Changes in alanine aminotransferase (ALT)
Number of patients with ALT \> 45 IU/L
Time frame: 30 days
Changes in alkaline phosphatase (ALP)
Number of patients with ALP \> 126 IU/L
Time frame: 30 days
Changes in Gamma-glutamyltransferase (GGT)
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Number of patients with GGT \> 117 IU/L
Time frame: 30 days
Changes in total bilirubin
Number of patients with total bilirubin \> 24 micromol/L
Time frame: 30 days
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 days
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 days
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 days
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 days
Glycemic control
Changes in fasting glucose (mmol/L)
Time frame: 30 days
Dietary intake
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 frame: 30 days
Questionnaires
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.
Time frame: 30 days
Intestinal microbiota composition
Changes from baseline of relative abundance (%) of bacterial phyla, genera and species between groups and within participants.
Time frame: 30 days
Fructose metabolites in feces
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.
Time frame: 30 days
Fructose metabolites in urine
Using 24h urine, the investigators will measure fecal concentrations of fructose metabolites such as ethanol, as well as SCFAs and bile acids.
Time frame: 30 days
Bioreactor analyses
Using specific anaerobic culturing, ethanol production of fecal samples will be assessed of bacterial strains.
Time frame: 30 days
MRI
Liver fat measured by proton density fat fraction (PDFF) MRI liver
Time frame: 30 days
FibroScan
Liver stiffness measured by FibroScan
Time frame: 30 days