Effects of ultra-processed foods on heart and metabolic health
Official title: A 2x2 Factorial Randomized Controlled Trial to Elucidate How Ultra-processed Foods Modulate Cardiometabolic Risk
Run by Laval University · NCT06538831 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Status | Recruiting |
| Started | September 25, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | August 31, 2028 |
| Registry record updated | October 17, 2024 |
| Trial ID | NCT06538831 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with existing cardiovascular disease, diabetes, or those on specific medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown varying results regarding the impact of diet on cardiometabolic health, but this specific factorial approach is relatively novel.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.