Status:
COMPLETED
Unravelling the Impact of Diet on Cardiovascular Health in Heterozygous Familial Hypercholesterolemia.
Lead Sponsor:
Laval University
Conditions:
Familial Hypercholesterolemia
Nutrition, Healthy
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 ...
Detailed Description
The research combines a dietary RCT (objectives 1, 2) and a cohort investigation (objective 3), both including adults with genetically-defined HeFH. The dietary intervention will be undertaken as a c...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Genetically-defined HeFH
- Premenopausal women with a regular menstrual cycle for \>3 months
- Postmenopausal women (without hormone replacement)
- Exclusion criteria:
- 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),
- Allergies/aversions to components of the experimental diets
- Any condition that would interfere with optimal participation in the intervention.
Exclusion
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05181553
Start Date
January 10 2022
End Date
June 30 2024
Last Update
September 10 2025
Active Locations (1)
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1
Institute on nutrition and functional foods, Laval University
Québec, Quebec, Canada, G1V0A6