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Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia

Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04837638
Acronym
FH-CAC
Enrollment
258
Registered
2021-04-08
Start date
2021-07-01
Completion date
2024-12-31
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcification; Heart, Diet Habit, Hypercholesterolemia, Familial

Brief 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. 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).

Interventions

BEHAVIORALDiet

No intervention. Cross-section assessment of the relationship between diet, medication, lifestyle and coronary artery calcification.

Sponsors

Centre de Recheche du Centre Hospitalier Université Laval
CollaboratorOTHER
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
CollaboratorOTHER
Laval University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

\- Genetically-defined heterozygous familial hypercholesterolemia

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Relationship between diet quality and coronary artery calcification (CAC)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.

Secondary

MeasureTime frameDescription
Relationship between diet quality and Lipoprotein (a).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.
Relationship between diet quality and intuitive eating.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.
Relationship between diet quality and physical activityDiet 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.
Relationship between diet quality and LDL-cholesterol.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.
Relationship between diet quality and substance use.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.
Relationship between diet quality and alcohol consumption.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.
Relationship between diet quality and medication adherence.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.
Relationship between diet quality and sleep.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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026