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Healthy Diet for High Cholesterol (FH-Diet Trial)

N/A
Recruiting
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 this analysis will compare ldl-c levels from plasma samples collected at the end (day 28) of each diet.
Awards & highlights

FH-Diet Trial 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.Check my eligibility
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.See study design
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.

FH-Diet Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a postmenopausal woman not on hormone replacement.
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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 familial hypercholesterolemia.

FH-Diet Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this analysis will compare ldl-c levels from plasma samples collected at the end (day 28) of each diet.
This trial's timeline: 3 weeks for screening, Varies for treatment, and this analysis will compare ldl-c levels from plasma samples collected at the end (day 28) of each diet. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-diet differences in LDL-C levels.
Secondary outcome measures
Association between the plasma metabolomic signature of the healthy CFG diet and cardiovascular disease prevalence.
Post-diet differences in plasma metabolomics profiles.

FH-Diet 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
421 Previous Clinical Trials
172,691 Total Patients Enrolled
Université de MontréalOTHER
216 Previous Clinical Trials
102,775 Total Patients Enrolled
Centre de Recheche du Centre Hospitalier Université LavalOTHER
4 Previous Clinical Trials
1,887 Total Patients Enrolled

Media Library

Canada's Food Guide principles (CFG diet) Clinical Trial Eligibility Overview. Trial Name: NCT05181553 — N/A
High Cholesterol Research Study Groups: Standard North American diet (NAD diet), Canada's Food Guide principles (CFG diet)
High Cholesterol Clinical Trial 2023: Canada's Food Guide principles (CFG diet) Highlights & Side Effects. Trial Name: NCT05181553 — N/A
Canada's Food Guide principles (CFG diet) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05181553 — N/A
~0 spots leftby Jun 2024
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