Impact of Ultra-processed Foods on Cardiometabolic Risk Factors
ConditionCardiometabolic Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLaval University
About this trial
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 criteria
Qualifiers
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%
Disqualifiers
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
Trial design
Treatments tested in this trial
- Diet N-P-
- Diet N+P-
- Diet N-P+
- Diet N+P+
Treatment groups
120 Participants
are divided into 4 treatment groupsSponsors and collaborators
Laval University
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov