Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
NCT Number: NCT06502834
Acronym: PIGER
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Obesity|Metabolic Syndrome|Steatosis of Liver
Interventions: DIETARY_SUPPLEMENT: D piger|DIETARY_SUPPLEMENT: Placebo
Sponsor: Max Nieuwdorp
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2024-12-01
Locations: Amsterdam UMC location AMC, Amsterdam, Netherlands

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.

Primary Outcome Measures: Gut engraftment, the number of reads of d piger in feces using q pcr, 30 days|adverse events, the number of adverse events in both groups, 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, 30 days|Occurence of anemia, Number of patients with Hb \< 8,5 mmol/L, 30 days|Changes in leucocytes, Number of patients with leucocytes \<4,0 or \>10,5 x10E9 cells/L, 30 days|Changes in thrombocytes, Number of patients with thrombocytes \<150 x 10E9 cells/, 30 days|Changes in aspartate aminotransferase (AST), Number of patients with AST \> 43 IU/L, 30 days|Changes in alanine aminotransferase (ALT), Number of patients with ALT \> 45 IU/L, 30 days|Changes in alkaline phosphatase (ALP), Number of patients with ALP \> 126 IU/L, 30 days|Changes in Gamma-glutamyltransferase (GGT), Number of patients with GGT \> 117 IU/L, 30 days|Changes in total bilirubin, Number of patients with total bilirubin \> 24 micromol/L, 30 days
Secondary Outcome Measures: 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, 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, 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., 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., 30 days|Glycemic control, Changes in fasting glucose (mmol/L), 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, 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., 30 days|Intestinal microbiota composition, Changes from baseline of relative abundance (%) of bacterial phyla, genera and species between groups and within participants., 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., 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., 30 days|Bioreactor analyses, Using specific anaerobic culturing, ethanol production of fecal samples will be assessed of bacterial strains., 30 days|MRI, Liver fat measured by proton density fat fraction (PDFF) MRI liver, 30 days|FibroScan, Liver stiffness measured by FibroScan, 30 days