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Impact of Ultra-processed Foods on Cardiometabolic Risk Factors

NCT06538831 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-10-17

No results posted yet for this 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.

Conditions

  • Cardiometabolic Risk

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Laval University

    lead OTHER

Principal Investigators

  • Benoît Lamarche, PhD · Laval University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2027-06-30
Completion
2028-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06538831 on ClinicalTrials.gov