NCT05181553Completed
Unravelling the Impact of Diet on Cardiovascular Health in Heterozygous Familial Hypercholesterolemia.
Unravelling the Impact of Diet on Cardiovascular Health in Heterozygous Familial Hypercholesterolemia: a Metabolomic Approach.
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 8 Nov 2021
- Start date
- 10 Jan 2022
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Laval University
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05181553
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 10 Jan 2022 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergies/aversions to components of the experimental diets
- Any condition that would interfere with optimal participation in the intervention.
Age
- Any cardiovascular disease-risk exacerbating conditions (age \>60 years, homozygous FH, personal history of cardiovascular disease, diabetes/anti-diabetic drug use, severe obesity, unstable body weight for \>3 months, uncontrolled hypertension, genetic hypertriglyceridemia),
Who the study is looking for
- Genetically-defined HeFH
- Premenopausal women with a regular menstrual cycle for \>3 months
- Postmenopausal women (without hormone replacement)
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute on nutrition and functional foods, Laval University Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.