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Behavioural Intervention
Healthy Diet for High Cholesterol
N/A
Waitlist Available
Led By Jean-Philippe Drouin-Chartier, PhD
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Premenopausal women with a regular menstrual cycle for more than 3 months
Genetically-defined HeFH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group
Summary
"This trial will study 10 adults with high cholesterol who are taking medication. They will be put on a diet low in red and processed meats and high in plant foods, following Canada's Food Guide.
Who is the study for?
This trial is for adults with a condition called Heterozygous Familial Hypercholesterolemia (HeFH) who are already taking medication to lower their cholesterol. Participants should be interested in seeing how changing their diet affects their health.
What is being tested?
The study tests the effects of a healthy diet low in red and processed meats and high in plant foods, based on Canada's Food Guide, compared to a standard North-American diet on bad cholesterol levels and blood markers.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include digestive adjustments or food sensitivities but are generally expected to be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a premenopausal woman with regular periods for over 3 months.
Select...
I have been diagnosed with genetic HeFH.
Select...
I am a postmenopausal woman not on hormone replacement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-diet differences in LDL-cholesterol concentrations.
Secondary study objectives
Post-diet differences in 10-year risk of atherosclerotic cardiovascular disease
Post-diet differences in C-reactive protein levels
Post-diet differences in other atherogenic lipoproteins and lipids
+2 moreOther study objectives
Post-diet differences in appetite sensation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard North American diet (NAD diet)Experimental Treatment1 Intervention
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.
Group II: Canada's Food Guide principles (CFG diet)Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Laval UniversityLead Sponsor
434 Previous Clinical Trials
178,627 Total Patients Enrolled
Jean-Philippe Drouin-Chartier, PhDPrincipal InvestigatorLaval University