Impact of Ultra-processed Foods on Cardiometabolic Risk Factors
Recruiting now · Not applicable
Conditions studied: Cardiometabolic Risk
In brief
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 weeks.
Key facts
- Study ID
- NCT06538831
- Run by
- Laval University
- People needed
- 120
- Starts
- 2024-09-25
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2024-10-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval — Québec, Quebec, Canada (enrolling)
Full record on ClinicalTrials.gov
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