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Behavioural Intervention

Canada's Food Guide principles (CFG diet) for Healthy Nutrition

N/A

Recruiting

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 this analysis will compare ldl-c levels from plasma samples collected at the end (day 28) of each diet

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ this analysis will compare ldl-c levels from plasma samples collected at the end (day 28) of each diet

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-cholesterol concentrations.

Secondary outcome measures

Post-diet differences in plasma metabolomics profiles

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

Find a Location

Who is running the clinical trial?

Laval UniversityLead Sponsor

420 Previous Clinical Trials

172,717 Total Patients Enrolled

Jean-Philippe Drouin-Chartier, PhDPrincipal InvestigatorLaval University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial have an age limit that excludes individuals older than 30 years?

"Individuals over 18 years and under 60 years are eligible for participation in this clinical investigation."

Answered by AI

Are new participants currently being recruited for this ongoing medical study?

"Indeed, data from clinicaltrials.gov shows that this research study is actively seeking volunteers. Originally shared on April 1st 2024, the trial was last revised on April 25th of the same year. The aim is to enroll a total of 10 participants at one designated site."

Answered by AI

Is it possible for me to participate in this research project?

"Individuals must exhibit proper nutrition and fall between the ages of 18 and 60 to be eligible for enrollment in this study, which has a capacity of accommodating up to 10 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Unravelling the Impact of Diet on Cardiovascular Health in Treated Heterozygous Familial Hypercholesterolemia.

Jean-Philippe Drouin-Chartier 2024. "Unravelling the Impact of Diet on Cardiovascular Health in Treated Heterozygous Familial Hypercholesterolemia.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06389825.

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