The role of gut microbiota in CHOline and CARnitine metabolism on vascular inflammation in metabolic syndrome; the ChoCar-trial

Completed

• Conditions: subjects with metabolic syndrome; intestinal choline and carnitine metabolism; TMAO; vascular inflammation

• Registration Number: NL-OMON24732
• Lead Sponsor: AMC

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

patients: treatment naive male obese patients with metabolic syndrome; 21 to 69 years-old; body mass index (BMI) 30 to 43 kg/m2

Exclusion Criteria

patients: Supplement use (including vitamin/choline/carnitine supplements, energy drinks and carnitine-enriched soymilk) is not allowed. Other exclusion criteria are a medical history of a cardiovascular event (myocardial infarction/stroke), cholecystectomy, use of medication including antacids and oral antibiotics in the past three months and immunodeficiency.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes in postprandial choline and carnitine metabolism (d6-labeled choline and d3-labeled carnitine) and fecal gutmicrobiota composition between baseline and 2 weeks after vegetarian/vegan microbial transplantation

Secondary Outcome Measures

Name	Time	Method
changes in vascular/intestinal wall inflammation (PETCT) between baseline and 2 weeks after vegetarian/vegan microbial transplantation. <br /><br>changes in plasma (monocyte) and subcutaneous adipose tissue inflammatory markers upon fecal transplantation