Clinical Trial

Impact of Ultra-processed Foods on Cardiometabolic Risk Factors

Study acronym: NOVA
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-31.
Status change: Not Yet Recruiting → Recruiting 2024-10-15
Trial Details
NCT Number NCT06538831
Lead Sponsor Laval University
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions Cardiometabolic Risk
Enrollment 120 participants
Start Date 2024-09-25
Primary Completion 2027-06-30 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-17