Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)

the number of reads of d piger in feces using q pcr

the number of adverse events in both groups

Number of participants with a decreased kidney function, defined as a rise in serum creatinine of >26,5 micromol/L in 48 h

Number of patients with Hb < 8,5 mmol/L

Number of patients with leucocytes <4,0 or >10,5 x10E9 cells/L

Number of patients with thrombocytes <150 x 10E9 cells/

Number of patients with AST > 43 IU/L

Number of patients with ALT > 45 IU/L

Number of patients with ALP > 126 IU/L

Number of patients with GGT > 117 IU/L

Number of patients with total bilirubin > 24 micromol/L

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

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

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.

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.

Changes in fasting glucose (mmol/L)

Participants are asked to fill out an online dietary questionnaire for the 3 days prior to study visit 2,3,4,5 and 7

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.

Changes from baseline of relative abundance (%) of bacterial phyla, genera and species between groups and within participants.

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.

Using 24h urine, the investigators will measure fecal concentrations of fructose metabolites such as ethanol, as well as SCFAs and bile acids.

Using specific anaerobic culturing, ethanol production of fecal samples will be assessed of bacterial strains.

Liver fat measured by proton density fat fraction (PDFF) MRI liver

Liver stiffness measured by FibroScan