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Impact of Ultra-processed Foods on Cardiometabolic Risk Factors

RecruitingNAAges 18 Years - 75 YearsAllLaval University
NCT06538831 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to examine in a 2x2 factorial RCT what feature(s) of ultra-processed foods (UPFs) contribute to cardiometabolic risk in men and women. The project's hypotheses are : 1. that the nutrient composition of UPFs (high SFA, free sugar and sodium) per se has deleterious impacts on cardiometabolic risk factors; 2. that the industrial techniques and processes of UPFs per se do not. Participants will be randomly assigned to one of 4 groups consistent with the 2x2 factorial design of the study: 1- the nutrient composition of foods (low vs. high in SFA, free sugar and sodium) and 2- the degree of industrial techniques and food processing (little to no vs.important amounts of UPFs). All foods will be provided to participants under isocaloric conditions during the 6-week dietary intervention. Participants will have to consume one of the 4 experimental diets for 6 w

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📋 Eligibility rules (as published)
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
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What it tests

  • Diet N-P-
  • Diet N+P-
  • Diet N-P+
  • Diet N+P+
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Where

1 site
Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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