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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03398889
Other study ID # 105166
Secondary ID
Status Completed
Phase N/A
First received December 12, 2017
Last updated January 11, 2018
Start date July 1, 2014
Est. completion date October 15, 2016

Study information

Verified date December 2017
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 316
Est. completion date October 15, 2016
Est. primary completion date October 15, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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,

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Stroke Prevention & Atherosclerosis Research Centre London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma levels of metabolites in the three phenotypes Plasma levels of trimethylamine n-oxide, p-cresylsulfate, hippuric acid, p-cresyl glucuronide, pheny acetyl glutamine and phenyl sulfate Day 1
Secondary Bacterial profile of the intestinal microbiome Amplification and sequencing of 16S rRNA gene variable regions Day 1
Secondary Effect of nutrient intake on plasma levels of metabolites Nutrient analysis from food frequency questionnaire Day 1
Secondary Effect of renal function on plasma levels of metabolites eGFR from CKD-EPI equations Day 1
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