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Intestinal Microbiome and Extremes of Atherosclerosis

Intestinal Microbiome and Extremes of Atherosclerosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03398889
Enrollment
316
Registered
2018-01-16
Start date
2014-07-01
Completion date
2016-10-15
Last updated
2018-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Microbiome, Atherosclerosis, Nutrients, Renal Function

Keywords

intestinal microbiome, atherosclerosis, nutrients, renal function

Brief 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.

Interventions

DIAGNOSTIC_TESTPlasma levels of metabolites

plasma levels of metabolites

Harvard food frequency questionnaire

DIAGNOSTIC_TESTIntestinal microbiome

amplification and sequencing of 16S rRNA gene variable regions in stool samples

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients attending stroke prevention clinics and a Premature Atherosclerosis Clinic at University Hospital, London, ON, Canada, * with measurements of carotid plaque burden and the risk factors used in the linear regression model. * Willing to consent to the protocol approved by the Ethics board

Exclusion criteria

* Missing data on variables used in the regression model,

Design outcomes

Primary

MeasureTime frameDescription
Plasma levels of metabolites in the three phenotypesDay 1Plasma levels of trimethylamine n-oxide, p-cresylsulfate, hippuric acid, p-cresyl glucuronide, pheny acetyl glutamine and phenyl sulfate

Secondary

MeasureTime frameDescription
Bacterial profile of the intestinal microbiomeDay 1Amplification and sequencing of 16S rRNA gene variable regions
Effect of nutrient intake on plasma levels of metabolitesDay 1Nutrient analysis from food frequency questionnaire
Effect of renal function on plasma levels of metabolitesDay 1eGFR from CKD-EPI equations

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026