Effects of ultra-processed foods on heart and metabolic health
A 2x2 Factorial Randomized Controlled Trial to Elucidate How Ultra-processed Foods Modulate Cardiometabolic Risk
This study is testing how different types of ultra-processed foods affect heart and metabolic health in men and women over six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06538831 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how different features of ultra-processed foods (UPFs) affect cardiometabolic risk factors in men and women. Participants will be randomly assigned to one of four dietary groups for a 6-week period, with diets varying in nutrient composition and levels of UPFs. The study aims to determine whether the nutrient content or the processing techniques of these foods contribute more significantly to health risks. All meals will be provided and controlled to ensure participants maintain a stable caloric intake throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 35 with a stable weight and specific health parameters related to cholesterol, blood pressure, and diabetes.
Not a fit: Patients with existing cardiovascular disease, diabetes, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary recommendations that may reduce cardiometabolic risks associated with ultra-processed foods.
How similar studies have performed: Previous studies have shown varying results regarding the impact of diet on cardiometabolic health, but this specific factorial approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body mass index (BMI):18 to 35 kg/m2 * Stable weight over the last 3 months (variation of less than 5 kg) * LDL-cholesterol \< 5.0 mmol/L * HbA1c \< 6.5% * Office blood pressure \<150/90 mmHg * Non-smokers or smokers of less than 10 cigarettes a day Exclusion Criteria: * Pregnant or breast-feeding women * Alcohol consumption of more than 7 drinks per week * Women: contraceptives for less than 3 months or hormone therapy for less than 6 months * Medication to treat hypercholesterolemia, diabetes or hypertension * Diagnosis of cardiovascular disease, diabetes, hypertension, cancer * Food allergies or aversions to any of the foods on the experimental menus * Being on a diet or following a special diet * Daytime MAPA blood pressure \>150/90
Where this trial is running
Québec, Quebec
- Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Benoît Lamarche, PhD — Laval University
- Study coordinator: Benoît Lamarche, PhD
- Email: benoit.lamarche@fsaa.ulaval.ca
- Phone: 418-656-3527
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.