No registrations found.
ID
Source
Brief title
Health condition
subjects with metabolic syndrome; intestinal choline and carnitine metabolism; TMAO; vascular inflammation
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
changes 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
Background summary
in 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)
Study objective
We 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.
Study design
0 and 2 weeks
Intervention
lean vegetarian/vegan donor feces
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
patients: 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 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.
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4188 |
| NTR-old | NTR4338 |
| CCMO | NL41928.018.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39717 |