120 Participants Needed

Ultra-processed Foods for Cardiometabolic Health

(NOVA Trial)

IG
BL
Overseen ByBenoît Lamarche, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

BL

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

LDL-cholesterol less than 5.0 mmol/L
HbA1c less than 6.5%
Office blood pressure less than 150/90 mmHg
See 3 more

Exclusion Criteria

Being on a diet or following a special diet
Alcohol consumption of more than 7 drinks per week
I have been using contraceptives for less than 3 months or hormone therapy for less than 6 months.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume one of four experimental diets for 6 weeks, with meals provided under isocaloric conditions to maintain body weight constant.

6 weeks
3 to 5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with measurements of cardiometabolic risk factors.

4 weeks

Treatment Details

Interventions

  • Ultra-processed Foods
Trial Overview The study tests how different aspects of ultra-processed foods affect heart health and diabetes risk. It compares effects of nutrient content (saturated fat, sugar, sodium) versus food processing techniques. Participants are randomly assigned to one of four diet groups in a controlled setting.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Diet N-P-Experimental Treatment1 Intervention
Group II: Diet N-P+Experimental Treatment1 Intervention
Group III: Diet N+P-Experimental Treatment1 Intervention
Group IV: Diet N+P+Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials
439
Recruited
178,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Findings from Research

Ultra-processed foods are strongly linked to an increased risk of various cardiometabolic issues, including obesity, type 2 diabetes, and cardiovascular disease, based on high-quality epidemiological and experimental studies.
Given the widespread consumption of ultra-processed foods and their associated health risks, they should be a primary focus for public health initiatives and clinical interventions aimed at improving diet quality.
Ultra-processed Foods and Cardiometabolic Health Outcomes: from Evidence to Practice.Juul, F., Deierlein, AL., Vaidean, G., et al.[2022]
High consumption of ultra-processed foods (UPF) is linked to a significant increase in the risk of overweight/obesity (39%), high waist circumference (39%), and metabolic syndrome (79%) based on a systematic review of 23 studies.
In a large cohort of 183,491 participants followed for 3.5 to 19 years, high UPF consumption was associated with a 25% increased risk of all-cause mortality and a 29% increased risk of cardiovascular disease, indicating serious long-term health risks.
Consumption of ultra-processed foods and health status: a systematic review and meta-analysis.Pagliai, G., Dinu, M., Madarena, MP., et al.[2023]
A systematic review of 11 studies found that the consumption of ultra-processed foods is positively associated with overweight, obesity, high blood pressure, and metabolic syndrome in adults and the elderly.
The Nova food classification is effective for evaluating the health impacts of food processing, but the evidence quality is moderate for obesity and weak for hypertension and metabolic syndrome, suggesting further research is needed.
Food processing and cardiometabolic risk factors: a systematic review.Santos, FSD., Dias, MDS., Mintem, GC., et al.[2020]

References

Ultra-processed Foods and Cardiometabolic Health Outcomes: from Evidence to Practice. [2022]
Consumption of ultra-processed foods and health status: a systematic review and meta-analysis. [2023]
Food processing and cardiometabolic risk factors: a systematic review. [2020]
Food consumption by degree of processing and cardiometabolic risk: a systematic review. [2021]
Use of Different Food Classification Systems to Assess the Association between Ultra-Processed Food Consumption and Cardiometabolic Health in an Elderly Population with Metabolic Syndrome (PREDIMED-Plus Cohort). [2021]
[Ultra-processed food : from research to guidelines]. [2022]
Ultra-Processed Food Consumption and Incidence of Obesity and Cardiometabolic Risk Factors in Adults: A Systematic Review of Prospective Studies. [2023]
Relative Validity of a Semi-Quantitative Food Frequency Questionnaire to Estimate Dietary Intake According to the NOVA Classification in Mexican Children and Adolescents. [2022]
Ultraprocessed food consumption and kidney function decline in a population-based cohort in the Netherlands. [2023]
Increased ultra-processed food consumption is associated with worsening of cardiometabolic risk factors in adults with metabolic syndrome: Longitudinal analysis from a randomized trial. [2023]
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