ChoCar trial; The role of gut microbiota in choline and carnitine metabolism on vascular inflammation in metabolic syndrome
Completed
- Conditions
- Atherosclerosisvessel calcification1001108210003216
- Registration Number
- NL-OMON39717
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Subjects: Kaukasian, adult, obese males with BMI >30 kg/m2 and metabolic syndrome, including increased fasting glucose
Donors: healthy, adult, lean males (BMI 20-25 kg/m2) on a vegetarian diet
Exclusion Criteria
Supplement use (including vitamin/choline/carnitine supplements, energy drinks and carnitine-enriched soymilk); a medical history of a cardiovascular event (myocardial infarction or stroke) or cholecystectomy; use of medication including antacids and 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint concerns changes in postprandial choline and carnitine<br /><br>metabolism at baseline and 2 weeks after vegetarian microbial transplantation.<br /><br>We hypothesize that post-treatment changes are caused by altered gut microbiota<br /><br>composition. Thus fecal samples will be obtained for relating these changes.<br /><br><br /><br>Changes in gut microbiota composition<br /><br>Morning stool samples will be collected at baseline, 1 and 2 weeks after start<br /><br>of the study to determine microbiota composition upon vegetarian microbial<br /><br>transplantation. Samples will be taken by collection on toilet paper or in a<br /><br>fecal container, to be directly frozen at -80 degrees C in the AMC. Fecal<br /><br>analysis will be done by HITChip array which is developed for exact and<br /><br>sensitive enumeration of bacterial population</p><br>
- Secondary Outcome Measures
Name Time Method