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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 below

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I am a premenopausal woman with regular periods for over 3 months.

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I have been diagnosed with genetic HeFH.

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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

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 more

Other 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.

0 / 3Eligibility criteria met