NCT03398889

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
Last Updated

January 16, 2018

Status Verified

December 1, 2017

Enrollment Period

2.3 years

First QC Date

December 12, 2017

Last Update Submit

January 11, 2018

Conditions

Gastrointestinal Microbiome, Atherosclerosis, NutrientsRenal Function

Keywords

intestinal microbiomeatherosclerosisnutrientsrenal function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Bacterial profile of the intestinal microbiome

    Day 1

  • Effect of nutrient intake on plasma levels of metabolites

    Day 1

  • Effect of renal function on plasma levels of metabolites

    Day 1

Study Arms (3)

Unexplained Atherosclerosis phenotype

Residual score in linear regression \>2

Diagnostic Test: Plasma levels of metabolitesBehavioral: Dietary questionnaireDiagnostic Test: Intestinal microbiome

Explained Atherosclerosis phenotype

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

Diagnostic Test: Plasma levels of metabolitesBehavioral: Dietary questionnaireDiagnostic Test: Intestinal microbiome

Protected Atherosclerosis phenotype

Residual score \<-2

Diagnostic Test: Plasma levels of metabolitesBehavioral: Dietary questionnaireDiagnostic Test: Intestinal microbiome

Interventions

Plasma levels of metabolitesDIAGNOSTIC_TEST

plasma levels of metabolites

Explained Atherosclerosis phenotypeProtected Atherosclerosis phenotypeUnexplained Atherosclerosis phenotype
Dietary questionnaireBEHAVIORAL

Harvard food frequency questionnaire

Explained Atherosclerosis phenotypeProtected Atherosclerosis phenotypeUnexplained Atherosclerosis phenotype
Intestinal microbiomeDIAGNOSTIC_TEST

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

Explained Atherosclerosis phenotypeProtected Atherosclerosis phenotypeUnexplained Atherosclerosis phenotype

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmale, female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

as above

You may qualify if:

  • 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

You may not qualify if:

  • Missing data on variables used in the regression model,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stroke Prevention & Atherosclerosis Research Centre

London, Ontario, N6G 2V4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples stored

MeSH Terms

Conditions

Atherosclerosis

Interventions

Gastrointestinal Microbiome

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MicrobiotaMicrobiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2017

First Posted

January 16, 2018

Study Start

July 1, 2014

Primary Completion

October 15, 2016

Study Completion

October 15, 2016

Last Updated

January 16, 2018

Record last verified: 2017-12

Locations

CA(1)