Diet N-P-: Low in saturated fatty acids (SFAs), free sugar and sodium; Low in ultra-processed foods (UPFs)
Diet N+P-: Rich in SFAs, free sugar and sodium; Low in UPFs
Diet N-P+: Low in SFAs, free sugar and sodium; High in UPFs
Diet N+P+: Rich in SFAs, free sugar and sodium; High in UPFs
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Post treatment fasting LDL-C concentrations — 6 weeks Fasting serum LDL-C concentrations (mmol/L) will be measured at the end of the 6-wk intervention in all subjects in each group, on two consecutive days post-treatment. The mean of the two post-treatment values will be used in the analyses. Analyses will be adjusted for LDL-C concentrations values measured at baseline.
Post treatment insulin sensitivity (HOMA-IR) — 6 weeks Insulin sensitivity (HOMA-IR) will be measured in the fasted state at the end of the 6-wk intervention in all subjects in each group, on two consecutive days post-treatment. The mean of the two post-treatment values will be used in the analyses. Analyses will be adjusted for insulin sensitivity (HOMA-IR) values measured in the fasted state at baseline.
Post treatment day-time ambulatory systolic blood pressure — 6 weeks Day-time ambulatory systolic blood pressure will be measured at the end of the 6-wk intervention in all subjects in each group. Analyses will be adjusted for day-time ambulatory systolic blood pressure values measured at baseline.
Trial sites (1)
Facility
City
Region
Status
Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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