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

NCT04837638 | Active Not Recruiting

• 1 other identifier: FH-CAC (MP-20-2021-5767)
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia, Familial; Calcification; Heart; Diet Habit

Outcome Measures

Primary Outcomes (1)

• 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.

  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 questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.

• Relationship between diet quality and Lipoprotein (a).

  Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.

• Relationship between diet quality and intuitive eating.

  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 questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.

• Relationship between diet quality and sleep.

  Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.

Study Arms (1)

Adults with HeFH

Adult men and women aged 18 to 65 years with genetically-defined HeFH.

Behavioral: Diet

Interventions

Diet BEHAVIORAL

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

Adults with HeFH

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult men and women with genetically-defined HeFH

You may qualify if:

• \- Genetically-defined heterozygous familial hypercholesterolemia

You may not qualify if:

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

Sponsors & Collaborators

• Laval University: lead
• Centre de Recheche du Centre Hospitalier Université Laval: collaborator
• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: collaborator

Study Sites (1)

Institute of nutrition and functional foods, Laval University

Québec, G1V0A6, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma.

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Calcinosis; Feeding Behavior

Interventions

Diet

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jean-Philippe Drouin-Chartier

  Laval University

  STUDY DIRECTOR

• Jean-Philippe Drouin-Chartier

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)