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


- candidate number15950
- NTR NumberNTR4338
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-dec-2013
- Secondary IDsNL41928.018.12 
- Public TitleThe role of gut microbiota in CHOline and CARnitine metabolism on vascular inflammation in metabolic syndrome; the ChoCar-trial
- Scientific TitleThe role of gut microbiota in CHOline and CARnitine metabolism on vascular inflammation in metabolic syndrome; the ChoCar-trial
- ACRONYMChoCar-trial
- hypothesisWe would like to investigate whether intestinal choline and carnitine metabolism by microbiota is a transmissible trait using fecal transplantation from either allogenic (lean vegetarian/vegan) or autologous (own) donors on a) postprandial choline (oral d6-labeled choline) and carnitine (oral d3-labeled carnitine) metabolism, b) vascular inflammation (PETCT) and c) subcutaneous adipose tissue inflammation in male obese subjects with metabolic syndrome.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteriapatients: treatment naive male obese patients with metabolic syndrome; 21 to 69 years-old; body mass index (BMI) 30 to 43 kg/m2

fecal donors: male healthy, lean, vegetarian/vegan ( 21 to 69 years old, BMI between 20 and 25 kg/m2, no medication use)
- Exclusion criteriapatients: 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.

donors: Presence of fecal bacterial pathogens and viruses; history of a cardiovascular event (myocardial infarction/stroke), cholecystectomy, use of medication including antacids and oral antibiotics in the past three months; Supplement use (including vitamin/choline/carnitine supplements, energy drinks and carnitine-enriched soymilk)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jun-2015
- Target number of participants50
- Interventionslean vegetarian/vegan donor feces
- Primary outcomechanges 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 outcomechanges in vascular/intestinal wall inflammation (PETCT) between baseline and 2 weeks after vegetarian/vegan microbial transplantation.
changes in plasma (monocyte) and subcutaneous adipose tissue inflammatory markers upon fecal transplantation
- Timepoints0 and 2 weeks
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
CVON
- PublicationsN/A
- Brief summaryin this trial we would like to investigate the causality of intestinal microbiota in carnitine/choline metabolism and TMAO levels in relation to PETCT based inflammation in male subjects with metabolic syndrome treated either with lean vegetarian/vegan donor (allogenic) or own feces (autologous)
- Main changes (audit trail)
- RECORD28-dec-2013 - 24-mei-2017


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