Ultra-processed Foods for Cardiometabolic Health

(NOVA Trial)

Recruiting at 1 trial location

Overseen By Benoît Lamarche, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Cholesterol, Diabetes, Hypertension

Disqualifiers: Pregnancy, Alcohol, Cardiovascular, Diabetes, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how various aspects of ultra-processed foods impact heart and metabolic health. Researchers aim to determine whether the nutrients in these foods, such as high sugar and salt, are harmful, or if the processing methods are the primary concern. Participants will consume specially provided meals to assist in this investigation. Ideal candidates maintain a stable weight, have normal blood pressure, and do not smoke heavily or have major health issues. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on diet and health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that consuming a lot of ultra-processed foods (UPFs) can harm health, particularly the heart and metabolism. Studies have found that diets high in UPFs often contain lower-quality nutrients and more added sugars and unhealthy fats, increasing the risk of obesity, heart disease, and even early death. Some reports suggest that eating more UPFs can raise the risk of heart and metabolic issues by 25% to 58%.

However, not all UPFs affect health in the same way. The risk can vary depending on the specific nutrients and the degree of processing. This trial aims to explore these differences further. While UPFs are common in many diets, understanding their impact is key to making healthier choices. Participants in this study will help identify which aspects of UPFs are most harmful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different combinations of nutrients and processing levels in ultra-processed foods might impact cardiometabolic health. Unlike traditional treatments for cardiometabolic conditions that often involve medications or lifestyle changes, this trial focuses on dietary interventions. The trial investigates four different diets: Diet N-P+, Diet N+P+, Diet N-P-, and Diet N+P-, each varying in nutrient and processing content. This approach could help identify specific dietary patterns that either benefit or harm heart and metabolic health, offering potential new dietary guidelines tailored to improve health outcomes.

What evidence suggests that this trial's treatments could be effective for cardiometabolic health?

This trial will explore the impact of different diets involving ultra-processed foods (UPFs) on cardiometabolic health. Studies have shown a strong link between consuming UPFs and a higher risk of heart and metabolic health problems. People who consume many UPFs have a 25% to 58% higher chance of developing these issues compared to those who consume fewer. Research also indicates that diets high in UPFs usually contain more added sugars, unhealthy fats, and salt, which can harm heart health. Specifically, for every 10% increase in UPF intake, the risk of heart disease rises by 12%. These findings suggest that both the ingredients and the processing of UPFs might contribute to these risks. ^{1 2 3 5 6}

Who Is on the Research Team?

Benoît Lamarche, PhD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Diet N-P- Experimental Treatment 1 Intervention

Group II: Diet N-P+ Experimental Treatment 1 Intervention

Group III: Diet N+P- Experimental Treatment 1 Intervention

Group IV: Diet N+P+ Experimental Treatment 1 Intervention

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+

Published Research Related to This Trial

Ultra-processed foods, which are heavily modified and often contain additives, have been linked to lower nutritional quality and increased risks of chronic diseases such as cancer, cardiovascular disease, and obesity, based on numerous global studies.

Public health authorities are now recommending a reduction in the consumption of ultra-processed foods, but more research is needed to understand the mechanisms behind their health impacts and to inform regulations on food additives and processing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ultra-processed food : from research to guidelines]. Srour, B., Chazelas, E., Touvier, M.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-processed Foods and Cardiometabolic Health Outcomes: from Evidence to Practice. Juul, F., Deierlein, AL., Vaidean, G., et al.[2022]

In a study of 5373 adults aged 55-75 with metabolic syndrome, higher consumption of ultra-processed foods (UPF) over 12 months was linked to negative changes in cardiometabolic risk factors, including increased weight, BMI, waist circumference, and elevated blood glucose levels.

The analysis showed that those in the highest quartile of UPF consumption experienced significant increases in several health markers, such as triglycerides and diastolic blood pressure, indicating that reducing UPF intake may be important for improving health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased ultra-processed food consumption is associated with worsening of cardiometabolic risk factors in adults with metabolic syndrome: Longitudinal analysis from a randomized trial. González-Palacios, S., Oncina-Cánovas, A., García-de-la-Hera, M., et al.[2023]

In a study of 78,346 participants over an average follow-up of 3.6 years, higher consumption of ultraprocessed foods (UPFs) was linked to a 27% increased risk of developing chronic kidney disease (CKD) or experiencing a significant decline in kidney function.

Participants in the highest quartile of UPF intake experienced a more rapid decline in estimated glomerular filtration rate (eGFR), indicating that high UPF consumption negatively impacts kidney health, regardless of overall diet quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultraprocessed food consumption and kidney function decline in a population-based cohort in the Netherlands. Cai, Q., Duan, MJ., Dekker, LH., et al.[2023]

A systematic review of 17 studies indicates that the consumption of ultra-processed foods (UPF) is significantly associated with an increased risk of general and abdominal obesity.

There is also evidence suggesting that UPF consumption may elevate the risk of cardiometabolic issues, such as hypertension, diabetes, and dyslipidemia, although more research is needed to fully understand these relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Food Consumption and Incidence of Obesity and Cardiometabolic Risk Factors in Adults: A Systematic Review of Prospective Studies. Mambrini, SP., Menichetti, F., Ravella, S., et al.[2023]

Consumption of ultra-processed foods (UPF) is positively associated with increased risks of noncommunicable chronic diseases (NCD), including obesity, hypertension, and metabolic syndrome, based on a systematic review of various studies.

There is a need for more standardized research methodologies and longitudinal studies to better understand the causal relationships between UPF intake and cardiometabolic risks, as current disparities in dietary assessments complicate comparisons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food consumption by degree of processing and cardiometabolic risk: a systematic review. Silva Meneguelli, T., Viana Hinkelmann, J., Hermsdorff, HHM., et al.[2021]

The study evaluated the effectiveness of a semi-quantitative food frequency questionnaire (SFFQ) in estimating dietary intake of ultra-processed foods (UPFs) and minimally processed foods (MPFs) among 382 Mexican children and adolescents, showing moderate agreement with two 24-hour dietary recalls.

The SFFQ demonstrated reasonable validity in ranking energy intake from UPFs and MPFs, with intraclass correlation coefficients indicating consistent results, which suggests it can be a useful tool for dietary assessments in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative Validity of a Semi-Quantitative Food Frequency Questionnaire to Estimate Dietary Intake According to the NOVA Classification in Mexican Children and Adolescents. Oviedo-Solís, CI., Monterrubio-Flores, EA., Cediel, G., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food processing and cardiometabolic risk factors: a systematic review. Santos, FSD., Dias, MDS., Mintem, GC., et al.[2020]

In a study of 5636 participants with overweight or obesity, the classification system used to define ultra-processed food (UPF) significantly affected the observed associations between UPF consumption and cardiometabolic risk markers, highlighting the importance of food classification in nutritional research.

Higher UPF consumption was linked to poorer dietary profiles and increased body mass index (BMI) and blood pressure, with specific associations varying depending on the classification system used, indicating that UPF may contribute to cardiometabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Martinez-Perez, C., San-Cristobal, R., Guallar-Castillon, P., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed foods and health status: a systematic review and meta-analysis. Pagliai, G., Dinu, M., Madarena, MP., et al.[2023]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001365

Ultraprocessed Foods and Their Association With ... High versus low UPF intake was linked to a 25% to 58% higher risk of cardiometabolic outcomes and a 21% to 66% higher risk of mortality.

2. bmj.com bmj.com/content/384/bmj-2023-077310

Ultra-processed food exposure and adverse health outcomes Greater exposure to ultra-processed food was associated with a higher risk of adverse health outcomes, especially cardiometabolic, common mental disorder, and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10561017/

Ultra-processed foods and cardiometabolic health Analyses show that the nutrient quality of diets with large amounts of ultra-processed foods are on average poorer, containing more added sugars ...

4. newsroom.heart.org newsroom.heart.org/news/excessive-ultraprocessed-foods-upfs-and-poor-nutrition-tied-to-poor-health

Excessive ultraprocessed foods (UPFs) and poor nutrition ... High versus low UPF intake was linked to a 25%-58% higher risk of cardiometabolic outcomes and a 21%-66% higher risk of mortality. More research ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949688825000103

The impact of ultra-processed foods on cardiovascular ... The results indicated a significant 12% increase in overall cardiovascular disease risk with every 10% increment in UPF intake. This risk extended to specific ...

6. nature.com nature.com/articles/s41591-025-03842-0

Ultraprocessed or minimally processed diets following ... Higher UPF intakes are associated with increased risks of obesity, cardiometabolic disease, and all-cause mortality. As a result, countries ...