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ID
Source
Brief title
Health condition
metabolic syndrome, obesity, insulin resistance, NAFLD
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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 outcome
- 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.
Background summary
Based on our animal data, we will investigate the optimal dose of daily oral E.halliii treatment with respect to safety, improvement in insulin sensitivity (clamp) and reduced liver fat content (NAFLD/NASH on liver MRI) in male subjects with metabolic syndrome.
Study objective
We hypothesize that daily oral administration of increasing dosages of Eubacterium hallii, an anaerobic intestinal bacterial strain, can exert beneficial effects on insulin sensitivity and liver fat.
Study design
0,1,2,4,5,6 weeks
Intervention
increasing daily dosages of eubacterium hallii (10e6, 10e8 and 10e10 cells/ml) for 4 weeks in male subjects with metabolic syndrome
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
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
- 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 < 240).
- Excessive weightloss of >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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4775 |
| NTR-old | NTR4913 |
| Other | : MEC 2014_215 |