Intestinal Microbiome and Extremes of Atherosclerosis

NCT ID: NCT03398889

Last Updated: 2018-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

316 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-01

Study Completion Date

2016-10-15

Brief Summary

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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

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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

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Gastrointestinal Microbiome, Atherosclerosis, Nutrients Renal Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Unexplained Atherosclerosis phenotype

Residual score in linear regression \>2

Plasma levels of metabolites

Intervention Type DIAGNOSTIC_TEST

plasma levels of metabolites

Dietary questionnaire

Intervention Type BEHAVIORAL

Harvard food frequency questionnaire

Intestinal microbiome

Intervention Type DIAGNOSTIC_TEST

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

Explained Atherosclerosis phenotype

Residual score in linear regression \<-2, \<2

Plasma levels of metabolites

Intervention Type DIAGNOSTIC_TEST

plasma levels of metabolites

Dietary questionnaire

Intervention Type BEHAVIORAL

Harvard food frequency questionnaire

Intestinal microbiome

Intervention Type DIAGNOSTIC_TEST

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

Protected Atherosclerosis phenotype

Residual score \<-2

Plasma levels of metabolites

Intervention Type DIAGNOSTIC_TEST

plasma levels of metabolites

Dietary questionnaire

Intervention Type BEHAVIORAL

Harvard food frequency questionnaire

Intestinal microbiome

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Plasma levels of metabolites

plasma levels of metabolites

Intervention Type DIAGNOSTIC_TEST

Dietary questionnaire

Harvard food frequency questionnaire

Intervention Type BEHAVIORAL

Intestinal microbiome

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stroke Prevention & Atherosclerosis Research Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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105166

Identifier Type: -

Identifier Source: org_study_id

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