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RECRUITING
NCT06538831
NA

Impact of Ultra-processed Foods on Cardiometabolic Risk Factors

Sponsor: Laval University

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.

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

Interventions

OTHER

Diet N-P-

Low in saturated fatty acids (SFAs), free sugar and sodium; Low in ultra-processed foods (UPFs)

OTHER

Diet N+P-

Rich in SFAs, free sugar and sodium; Low in UPFs

OTHER

Diet N-P+

Low in SFAs, free sugar and sodium; High in UPFs

OTHER

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