Ultra-processed Foods for Cardiometabolic Health
(NOVA Trial)
Trial Summary
Will I have to stop taking my current medications?
If you are taking medication for high cholesterol, diabetes, or high blood pressure, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.
What data supports the effectiveness of the treatment Ultra-processed Foods for Cardiometabolic Health?
Research shows that high consumption of ultra-processed foods is linked to an increased risk of health issues like obesity, high blood pressure, and metabolic syndrome, which are all related to poor cardiometabolic health. This suggests that reducing ultra-processed food intake could potentially improve these health markers.12345
Is it safe to consume ultra-processed foods?
Research suggests that high consumption of ultra-processed foods is linked to increased risks of obesity, diabetes, heart disease, and even higher mortality rates. These foods often contain additives and undergo processing that may have negative health effects, so it's generally recommended to limit their intake.26789
How does the treatment of ultra-processed foods differ from other treatments for cardiometabolic health?
Ultra-processed foods are unique in that they are not a traditional treatment but rather a dietary factor associated with increased risk of cardiometabolic issues like obesity and high blood pressure. Unlike medications or lifestyle interventions aimed at improving health, ultra-processed foods are linked to worsening health outcomes, highlighting the importance of reducing their consumption for better cardiometabolic health.135710
What is the purpose of 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.
Research Team
Benoît Lamarche, PhD
Principal Investigator
Laval University
Eligibility Criteria
This trial is for men and women who are at risk of heart disease and diabetes (cardiometabolic risk). Participants will be eating specific diets provided by the study for 6 weeks. People with dietary restrictions or health conditions that could interfere with the diet or results may not qualify.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume one of four experimental diets for 6 weeks, with meals provided under isocaloric conditions to maintain body weight constant.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with measurements of cardiometabolic risk factors.
Treatment Details
Interventions
- Ultra-processed Foods
Find a Clinic Near You
Who Is Running the Clinical Trial?
Laval University
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator