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Impact of Ultra-processed Foods on Cardiometabolic Risk Factors
Sponsor: Laval University
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.
Official title: A 2x2 Factorial Randomized Controlled Trial to Elucidate How Ultra-processed Foods Modulate Cardiometabolic Risk
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-09-25
Completion Date
2028-08-31
Last Updated
2024-10-17
Healthy Volunteers
Yes
Conditions
Interventions
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
Locations (1)
Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval
Québec, Quebec, Canada