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

NCT05181553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-10

No results posted yet for this study

Summary

The investigators will first conduct a fully controlled dietary randomized crossover trial (RCT) including 50 adults with HeFH to investigate the impact of a whole food plant-based (WFPB) 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. Such a robust design will also lead to the identification an objective proxy to healthy diet adherence: the metabolomic signature. Secondly, by leveraging a cross-sectional cohort of adults with HeFH, the investigators will evaluate the relationship between the metabolomic signature of the healthy diet and cardiovascular disease risk factors in HeFH.

Conditions

  • Familial Hypercholesterolemia
  • Nutrition, Healthy
  • Cholesterol, Elevated
  • Cholesterol; Metabolic Disorder
  • Cardiovascular Diseases

Interventions

OTHER

Whole-food plant based diet (WFPB diet)

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

OTHER

Standard North American diet (SAD diet)

28-day fully controlled dietary intervention during which participants will receive a diet that reflects the eating habits of Canadians.

Sponsors & Collaborators

  • Laval University

    lead OTHER

Principal Investigators

  • Jean-Philippe Drouin-Chartier · Laval University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05181553 on ClinicalTrials.gov