Gastrointestinal Microbiome, Atherosclerosis, NutrientsNCT03398889
Intestinal Microbiome and Extremes of Atherosclerosis
An observational study of Gastrointestinal Microbiome, Atherosclerosis, Nutrients and Renal Function, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Microbiome, Atherosclerosis, Nutrients, Renal Function
- What is being tested?
- Plasma levels of metabolites, Dietary questionnaire and Intestinal microbiome
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 316 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2014to 15 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: as above
Who may be able to join
- 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
Who cannot join
- Missing data on variables used in the regression model,
Trial locations and contacts
1 site in 1 country.
Canada1 site
Stroke Prevention & Atherosclerosis Research Centre
London, Ontario, N6G 2V4
About this study
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.
Read the 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.
- Being tested
- Plasma levels of metabolites, Dietary questionnaire, Intestinal microbiome
- Keywords
- intestinal microbiome, atherosclerosis, nutrients, renal function
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma levels of metabolitesDiagnostic test
plasma levels of metabolites
Dietary questionnaireBehavioural
Harvard food frequency questionnaire
Intestinal microbiomeDiagnostic test
amplification and sequencing of 16S rRNA gene variable regions in stool samples
| Study group | Role | What they receive |
|---|---|---|
| Unexplained Atherosclerosis phenotype | Residual score in linear regression >2 Receives: Diagnostic Test: Plasma levels of metabolites; Behavioral: Dietary questionnaire; Diagnostic Test: Intestinal microbiome | |
| Explained Atherosclerosis phenotype | Residual score in linear regression <-2, <2 Receives: Diagnostic Test: Plasma levels of metabolites; Behavioral: Dietary questionnaire; Diagnostic Test: Intestinal microbiome | |
| Protected Atherosclerosis phenotype | Residual score <-2 Receives: Diagnostic Test: Plasma levels of metabolites; Behavioral: Dietary questionnaire; Diagnostic Test: Intestinal microbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (3)
Bacterial profile of the intestinal microbiome
Amplification and sequencing of 16S rRNA gene variable regions
Measured: Day 1
Effect of nutrient intake on plasma levels of metabolites
Nutrient analysis from food frequency questionnaire
Measured: Day 1
Effect of renal function on plasma levels of metabolites
eGFR from CKD-EPI equations
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start1 Jul 2014
- Primary completion15 Oct 2016
- Study completion15 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Microbiome, Atherosclerosis, NutrientsStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398889
- Sponsor's protocol ID
- 105166
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will depend on requests.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiome and Extremes of Atherosclerosis
- ClinicalTrials.gov ID
- NCT03398889
- Acronym / sponsor ID
- 105166
- Keywords
- intestinal microbiome, atherosclerosis, nutrients, renal function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 15 Oct 2016 (actual)
- Study completion
- 15 Oct 2016 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unexplained Atherosclerosis phenotype | – | Diagnostic Test: Plasma levels of metabolites, Behavioral: Dietary questionnaire, Diagnostic Test: Intestinal microbiomeResidual score in linear regression >2 |
| Explained Atherosclerosis phenotype | – | Diagnostic Test: Plasma levels of metabolites, Behavioral: Dietary questionnaire, Diagnostic Test: Intestinal microbiomeResidual score in linear regression <-2, <2 |
| Protected Atherosclerosis phenotype | – | Diagnostic Test: Plasma levels of metabolites, Behavioral: Dietary questionnaire, Diagnostic Test: Intestinal microbiomeResidual score <-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- as above
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Missing data on variables used in the regression model,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma levels of metabolitesplasma levels of metabolites | Diagnostic test | Explained Atherosclerosis phenotype, Protected Atherosclerosis phenotype, Unexplained Atherosclerosis phenotype |
| Dietary questionnaireHarvard food frequency questionnaire | Behavioural | Explained Atherosclerosis phenotype, Protected Atherosclerosis phenotype, Unexplained Atherosclerosis phenotype |
| Intestinal microbiomeamplification and sequencing of 16S rRNA gene variable regions in stool samples | Diagnostic test | Explained Atherosclerosis phenotype, Protected Atherosclerosis phenotype, Unexplained Atherosclerosis phenotype |
Primary outcome
Plasma levels of metabolites in the three phenotypes
Time frame: Day 1
Plasma levels of trimethylamine n-oxide, p-cresylsulfate, hippuric acid, p-cresyl glucuronide, pheny acetyl glutamine and phenyl sulfate
3 secondary outcomes
Bacterial profile of the intestinal microbiome
Time frame: Day 1
Effect of nutrient intake on plasma levels of metabolites
Time frame: Day 1
Effect of renal function on plasma levels of metabolites
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Individual participant dataSharing planned: Undecided. It will depend on requests.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Microbiome, Atherosclerosis, Nutrients and Renal Function, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of metabolites in the three phenotypes (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.