NCT03398889

Intestinal Microbiome and Extremes of Atherosclerosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 316 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients attending stroke prevention clinics and a premature atherosclerosis clinic at University Hospital in London, ON, Canada were recruited to the study. They completed a dietary questionnaire, provided stool samples and had blood drawn to measure plasma levels of metabolites produced by the intestinal bacteria.

Detailed description

Patients were phenotyped by their residual score in linear multiple regression with measured carotid plaque burden as the dependent variable and coronary risk factors were predictors. The residual score essentially represents the distance off the regression line of predicted plaque. They were grouped into three categories: Unexplained atherosclerosis (with more plaque than predicted by risk factors; residual score \>2); Explained (the amount of plaque predicted by risk factors, residual score \>-2 and \<2); and Protected (less plaque than predicted by risk factors, residual score \<-2). DNA was extracted from stool samples in the lab of Dr. Allen-Vercoe at University of Guelph. RNA makeup of the intestinal microbiome was assessed in the lab of Dr. Gregory Gloor at Western. Plasma levels of trimethylamine n-oxide, p-cresylsulfate, hippuric acid, p-cresyl glucuronide, pheny acetyl glutamine and phenyl sulfate were measured by ultra-performance liquid chromatography coupled to quadrupole time-of-flight mass spectrometry in the lab of Dr. Bradley Urquhart at Western. Nutrient intake over the past year was calculated at the Harvard School of Public Health from the 131 item self-reported and semi-quantitative Harvard Food Frequency Questionnaire (FFQ). Estimated glomerular filtration rate was calculated from the Chronic Kidney Disease Epidemiological (CKD-EPI) equations.

Conditions

• Gastrointestinal Microbiome, Atherosclerosis, Nutrients
• Renal Function

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Plasma levels of metabolites	plasma levels of metabolites
BEHAVIORAL	Dietary questionnaire	Harvard food frequency questionnaire
DIAGNOSTIC_TEST	Intestinal microbiome	amplification and sequencing of 16S rRNA gene variable regions in stool samples

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-10-15
• Completion: 2016-10-15
• First posted: 2018-01-16
• Last updated: 2018-01-16

Locations

1 site across 1 country: Canada