Unravelling the Impact of Diet on Cardiovascular Health in Treated Heterozygous Familial Hypercholesterolemia.

NCT06389825 | Completed

• 1 other identifier: FH-Diet-RX
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a fully controlled dietary randomized crossover trial (RCT) including 10 adults with HeFH using lipid-lowering medication to investigate the impact of a diet low in red and processed meats and high in plant foods, reflecting Canada's Food Guide, in place of a standard North-American diet on LDL-cholesterol (LDL-C) levels and the plasma metabolome.

Conditions

Familial Hypercholesterolemia; Nutrition, Healthy; Cholesterol, Elevated

Outcome Measures

Primary Outcomes (1)

• Post-diet differences in LDL-cholesterol concentrations.

  Investigators will evaluate the impact of a diet low in red and processed meats and high in plant foods in place of a standard North American diet on LDL-cholesterol concentrations among 10 adults with HeFH.

  This analysis will compare LDL-C levels from plasma samples collected at the end (day 28) of each diet

Secondary Outcomes (5)

• Post-diet differences in other atherogenic lipoproteins and lipids

  This analysis will compare levels of atherogenic lipoproteins and lipids measured from plasma samples collected at the end (day 28) of each diet

• Post-diet differences in C-reactive protein levels

  This analysis will compare C-reactive protein levels (mg/L) measured at the end (day 28) of each diet.

• Post-diet differences in systolic and diastolic blood pressure

  This analysis will compare systolic and diastolic blood pressure (mm Hg) measured at the end (day 28) of each diet.

• Post-diet differences in 10-year risk of atherosclerotic cardiovascular disease

  This analysis will compare 10-year risk of atherosclerotic cardiovascular disease (%) measured at the end (day 28) of each diet.

• Post-diet differences in plasma metabolomics profiles

  This analysis will compare metabolomic profiles from plasma samples collected at the end (day 28) of each diet.

Other Outcomes (1)

• Post-diet differences in appetite sensation

  Appetite sensation was measured at the end of the first (day 7) and the last week (day 28) of each diet. Changes between day 28 and day 7 will be calculated and compared between diet.

Study Arms (2)

Canada's Food Guide principles (CFG diet)

EXPERIMENTAL

During 28 days, participants will receive de CFG diet. The CFG diet emphasizes low intakes of red and processed meats and high intakes of minimally processed plant foods with water as the drink of choice, as per Canada's Food Guide. The number of portions of protein foods, whole-grains, fruits and vegetables to be served daily reflects the recommended ¼-¼-½ proportions. Regarding protein quality, vegetable proteins are served more often than animal proteins as stated in Canada's Food Guide. Weekly, red meat is served once, two days are meatless, and one day is free of animal products.

Other: Healthy diet

Standard North American diet (NAD diet)

EXPERIMENTAL

During 28 days, participants will receive de NAD diet. The NAD diet reflects current dietary intakes of the French-Canadian adult population in terms of foods, nutrients, and diet quality, as characterized in recent surveys conducted in an age- and a sex-representative sample of adults from the Province of Quebec. Intakes of minimally processed fruits and vegetables will be low; animal proteins, mostly red and processed meats, will be consumed more often than vegetable proteins; grains will be mostly refined; and ready-to-eat/ready-to-heat foods and sugary beverages will be served daily.

Other: Healthy diet

Interventions

Healthy diet OTHER

28-day fully controlled dietary intervention during which participants will receive a diet that reflects the recommendations of Canada's Food Guide.

Canada's Food Guide principles (CFG diet); Standard North American diet (NAD diet)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Genetically-defined HeFH
• Premenopausal women with a regular menstrual cycle for \>3 months
• Postmenopausal women (without hormone replacement)

You may not qualify if:

• Age \>60 years
• Homozygous FH
• Personal history of cardiovascular disease
• Prevalent diabetes or anti-diabetic drug use
• Severe obesity
• Unstable body weight for \>3 months
• Uncontrolled hypertension
• Genetic hypertriglyceridemia
• Allergies/aversions to components of the experimental diets
• Any other condition that would interfere with optimal participation in the intervention.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

INAF-NUTRISS Université Laval

Québec, Quebec, G1V0a6, Canada

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Hypercholesterolemia

Interventions

Diet, Healthy

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jean-Philippe Drouin-Chartier, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 29, 2024
• Study Start: April 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

CA (1)