Dosefinding trial studying effect of 4 weeks Intervention on safety and efficacy in males with Metabolic syndrome with oral Eubacterium hallii

Completed

• Conditions: metabolic syndrome, obesity, insulin resistance, NAFLD

• Registration Number: NL-OMON22563
• Lead Sponsor: AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 27

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

Exclusion Criteria

- History of cardiovascular event (myocardial infarction or pacemaker implantation)

- Cholecystectomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Safety (plasma biochemistry eg hepatic /inflammatory/cholesterol markers) and <br>increase in fecal E. hallii levels upon increasing dosages of daily oral Ehallii treatment<br /><br>- Insulin sensitivity as assessed by hyperinsulinemic clamp using stable isotope infusion) at baseline and 4 weeks upon increasing dosages of daily oral Ehallii treatment<br>

Secondary Outcome Measures

Name	Time	Method
- Effect on daily dietary intake and bowel habits (monitored using standardized questionnaires) <br /><br>- Intestinal fecal microbiota composition (including fecal E. hallii) upon increasing dosages of daily oral Ehallii treatment<br /><br>- Effects on bile acid metabolism in 24h feces<br /><br>- Liver fat content (hepatic MRI) upon increasing dosages of daily oral Ehallii treatment<br /><br>- Persistance of fecal E.hallii after cessation of 4 weeks treatment by collecting fecal samples at 5 and 6 weeks.