Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia (FH-CAC)

March 11, 2024 updated by: Jean-Philippe Drouin-Chartier, Laval University
The overarching objective is to evaluate the relationship between diet and coronary artery calcification in patients with heterozygous familial hypercholesterolemia (HeFH). We will recruit adults with HeFH. They will have to complete questionnaires on diet, medication and lifestyle. Coronary artery calcification will be measured in each patient using a CT scan. Physiological and biochemical data will be collected.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed research will deploy as cross-sectional study including treated adults with genetically-defined HeFH. Once recruited, participants will be asked to complete web-based questionnaires on diet, medication and lifestyle. They will thereafter complete a clinical assessment at the Clinical Investigation Unit of the NUTRISS-INAF Research Centre. Study staff will measure participants' height, weight, and waist circumference. Participants' blood pressure will be measured using an automatic blood pressure monitor (BP Thru, Omron) after sitting quietly for 10 minutes. Three sequential readings will be taken with three minutes between readings. Fasting blood samples (10 mL) will be collected from an antecubital vein. Body composition will be assessed with dual-energy X-ray absorptiometry (DEXA). Finally, participants will be asked to provide the full list of medication they are using, including type, dose and duration of use. Later on the same day, participants will undergo the non-contrast CT scan at the Quebec Heart and Lung Institute. Multidetector CT scans without contrast will be performed using a 256 slices helical scanner (Brilliance iCT, Philips).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
258

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
      • Québec, Canada, G1V0A6
        • Institute of nutrition and functional foods, Laval University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult men and women with genetically-defined HeFH

Description

Inclusion Criteria:

- Genetically-defined heterozygous familial hypercholesterolemia

Exclusion criteria:

  • Homozygous FH
  • Personal history of cardiovascular disease
  • Personal history of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adults with HeFH
Adult men and women aged 18 to 65 years with genetically-defined HeFH.
Behavioral: Diet
No intervention. Cross-section assessment of the relationship between diet, medication, lifestyle and coronary artery calcification.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relationship between diet quality and coronary artery calcification (CAC)
Time Frame: Diet questionnaire completion and CAC measurement will be completed with a 3 weeks period.
Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. CAC will be measured using non-constrat CT scan. CAC scores will be quantified with the Agatston scoring method. Higher CAC scores reflect higher CAC.
Diet questionnaire completion and CAC measurement will be completed with a 3 weeks period.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relationship between diet quality and LDL-cholesterol.
Time Frame: Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.
Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. LDL-cholesterol will be measured using standard procedures from the fasting blood sample collected on the same day of the CT-scan.
Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.
Relationship between diet quality and Lipoprotein (a).
Time Frame: Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.
Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. Lipoprotein (a) will be measured using standard procedures from the fasting blood sample collected on the same day of the CT-scan.
Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.
Relationship between diet quality and intuitive eating.
Time Frame: Diet questionnaire completion and psychological aspects of eating measurement will be completed with a 3 weeks period.
Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. Intuitive eating will be measured using the Intuitive Eating Scale.
Diet questionnaire completion and psychological aspects of eating measurement will be completed with a 3 weeks period.
Relationship between diet quality and physical activity
Time Frame: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Physical activity will be assessed using the Godin physical activity questionnaire.
Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Relationship between diet quality and sleep.
Time Frame: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Sleep will be assessed using the Pittsburgh Sleep Quality Index.
Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Relationship between diet quality and substance use.
Time Frame: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). substance use will be assessed in a self-reported fashion using a questionnaire.
Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Relationship between diet quality and alcohol consumption.
Time Frame: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Alcohol consumption will be assessed from the food frequency questionnaire.
Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Relationship between diet quality and medication adherence.
Time Frame: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Medication adherence will be assessed using the Medication Adherence Report Scale.
Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Centre de Recheche du Centre Hospitalier Université Laval

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Philippe Drouin-Chartier, Laval University
  • Study Director: Jean-Philippe Drouin-Chartier, Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FH-CAC (MP-20-2021-5767)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings