metabolic syndrome, obesity, insulin resistance, NAFLD
Conditions
Interventions
increasing daily dosages of eubacterium hallii (10e6, 10e8 and 10e10 cells/ml) for 4 weeks in male subjects with metabolic syndrome
Sponsors
AMC
Eligibility
Inclusion criteria
Inclusion criteria: -Caucasian obese subjects with metabolic syndrome (males, aged 21 to 69 years-old; body mass index (BMI) 25 to 43 kg/m2, fasting plasma glucose > 5.6 mmol/l, fasting triglycerides > 1.7 mmol/l, waist circumference > 102 cm) - No concomitant medication - Regular stool pattern
Exclusion criteria
Exclusion criteria: - History of cardiovascular event (myocardial infarction or pacemaker implantation) - Cholecystectomy - Use of medication including proton pump inhibitors - Oral anticoagulants and/or oral antibiotics in the past three months - (Expected) prolonged compromised immunity (e.g. due to recent cytotoxic chemotherapy or HIV-infection with a CD4 count 10% in the last months - Overt untreated GI disease/abnormal bowelhabits; - Levels of plasma aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) are 2.5 times or more the upper limit of the normal range - History of heavy alcohol use (>12 to 15 g of alcohol per day, or >12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits) - Overt DM2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety (plasma biochemistry eg hepatic /inflammatory/cholesterol markers) and increase in fecal E. hallii levels upon increasing dosages of daily oral Ehallii treatment - Insulin sensitivity as assessed by hyperinsulinemic clamp using stable isotope infusion) at baseline and 4 weeks upon increasing dosages of daily oral Ehallii treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Effect on daily dietary intake and bowel habits (monitored using standardized questionnaires) - Intestinal fecal microbiota composition (including fecal E. hallii) upon increasing dosages of daily oral Ehallii treatment - Effects on bile acid metabolism in 24h feces - Liver fat content (hepatic MRI) upon increasing dosages of daily oral Ehallii treatment - Persistance of fecal E.hallii after cessation of 4 weeks treatment by collecting fecal samples at 5 and 6 weeks. | — |
Contacts
Public ContactM. Nieuwdorp
AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2
Outcome results
None listed