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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo vial (10ml of glycerol 10% and 10% maltrodextrin) |
|
| D piger | Experimental | D. piger vial with 109 colony forming units (CFU) (=108 CFU D. piger per ml in 10ml of glycerol 10% and 10% maltrodextrin). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D piger | Dietary Supplement | Probiotic d piger |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion:
Male or (postmenopausal) females
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| M Nieuwdorp, prof dr | Contact | 020-5669111 | m.nieuwdorp@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Max Nieuwdorp, prof dr | Amsterdam UMC, location AMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC location AMC | Recruiting | Amsterdam | Netherlands |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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2x10 participants will be randomly allocated to placebo or d piger suspension once daily.
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The pharmacist will provide the study intervention to the investigator in a coded fashion. Both the investigator and the participant are blinded.
In case of emergency, an unblinding protocol is activated.
| Dietary Supplement |
Placebo |
|
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 |
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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |