Hypercholesterolemia, FamilialFH-CACNCT04837638
Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia
An observational study of Hypercholesterolemia, Familial and Calcification; Heart, run by Laval University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Familial, Calcification; Heart, Diet Habit
- What is being tested?
- Diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 258 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2021to 31 Dec 2024
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult men and women with genetically-defined HeFH
Who may be able to join
- Genetically-defined heterozygous familial hypercholesterolemia
Who cannot join
- Homozygous FH
- Personal history of cardiovascular disease
- Personal history of cancer
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of nutrition and functional foods, Laval University
Québec, G1V0A6
About this study
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.
Read the 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).
- Being tested
- Diet
- Medical subject headings
- Hyperlipoproteinemia Type II, Calcinosis, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
No intervention. Cross-section assessment of the relationship between diet, medication, lifestyle and coronary artery calcification.
| Study group | Role | What they receive |
|---|---|---|
| Adults with HeFH | Adult men and women aged 18 to 65 years with genetically-defined HeFH. Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between diet quality and coronary artery calcification (CAC)
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.
Measured: Diet questionnaire completion and CAC measurement will be completed with a 3 weeks period.
Secondary outcomes (8)
Relationship between diet quality and LDL-cholesterol.
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.
Measured: Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.
Relationship between diet quality and Lipoprotein (a).
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.
Measured: Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.
Relationship between diet quality and intuitive eating.
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.
Measured: Diet questionnaire completion and psychological aspects of eating measurement will be completed with a 3 weeks period.
Relationship between diet quality and physical activity
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.
Measured: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Relationship between diet quality and sleep.
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.
Measured: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Relationship between diet quality and substance use.
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.
Measured: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Relationship between diet quality and alcohol consumption.
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.
Measured: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Relationship between diet quality and medication adherence.
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.
Measured: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jul 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercholesterolemia, FamilialStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recheche du Centre Hospitalier Université Laval, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Responsible party
- Principal investigator, Jean-Philippe Drouin-Chartier, Laval University
- Investigators
- Jean-Philippe Drouin-Chartier, Study director, Laval UniversityJean-Philippe Drouin-Chartier, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837638
- Sponsor's protocol ID
- FH-CAC (MP-20-2021-5767)
- Acronym
- FH-CAC
- Status last verified
- Mar 2024
- First submitted
- 6 Apr 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04837638
- Acronym / sponsor ID
- FH-CAC / FH-CAC (MP-20-2021-5767)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Centre de Recheche du Centre Hospitalier Université Laval, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Apr 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with HeFH | – | Behavioral: DietAdult men and women aged 18 to 65 years with genetically-defined HeFH. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men and women with genetically-defined HeFH
Key inclusion criteria (1 listed)
- Genetically-defined heterozygous familial hypercholesterolemia
Key exclusion criteria (3 listed)
- Homozygous FH
- Personal history of cardiovascular disease
- Personal history of cancer
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 |
|---|---|---|
| DietNo intervention. Cross-section assessment of the relationship between diet, medication, lifestyle and coronary artery calcification. | Behavioural | Adults with HeFH |
Primary outcome
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.
8 secondary outcomes
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.
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.
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.
Relationship between diet quality and physical activity
Time frame: 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.
Relationship between diet quality and substance use.
Time frame: 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.
Relationship between diet quality and medication adherence.
Time frame: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Jean-Philippe Drouin-Chartier study director
Laval University
Jean-Philippe Drouin-Chartier principal investigator
Laval University
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 Hypercholesterolemia, Familial and Calcification; Heart, run by Laval University 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. 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?
Results are not available in the source record.
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?
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.). 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 13 Mar 2024.