← Back to Search

Healthy Diet for High Cholesterol (FH-Diet Trial)

N/A

Waitlist Available

Research Sponsored by Laval University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postmenopausal women (without hormone replacement)

Premenopausal women with a regular menstrual cycle for >3 months

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 the effects of a healthy diet on cholesterol levels and the metabolome in people with HeFH. The investigators will also study how a healthy diet affects cardiovascular disease risk in this population.

Who is the study for?

This trial is for adults with a genetic condition called HeFH, which leads to high cholesterol. It's open to premenopausal women with regular menstrual cycles and postmenopausal women not on hormone therapy. People over 60, those with heart disease or severe obesity, uncontrolled blood pressure, diabetes, or allergies to the diet components can't join.

What is being tested?

The study compares two diets: the standard North American diet (NAD) and one based on Canada's Food Guide (CFG), which is low in red meat and high in plants. The goal is to see how these diets affect bad cholesterol levels and identify markers that show if someone's following a healthy diet.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include digestive adjustments as your body adapts to new foods from either the NAD or CFG diets.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a postmenopausal woman not on hormone replacement.

Select...

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

Select...

I have been diagnosed with familial hypercholesterolemia.

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-C levels.

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

Association between the plasma metabolomic signature of the healthy CFG diet and LDL-C levels

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