Processed vs Minimally Processed Foods for Metabolic Health

(PFR Trial)

Overseen By Zach Hutelin

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: Diabetes, Metabolic disorder, Neurologic disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 hours per session

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to understand how ultra-processed foods (UPFs) and minimally processed foods (MPFs) affect metabolic health, focusing on why UPFs might lead to overeating. Participants will consume meals containing either UPFs or MPFs, and researchers will measure their body's responses. Participants will also engage in a task to assess how much they value different types of food. This study suits individuals living in the Roanoke area with a BMI between 18.5 and 24.9, who do not have metabolic disorders, and can comfortably undergo an MRI scan. As an unphased study, it offers participants the chance to contribute to groundbreaking research on dietary impacts on health.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves metabolic measurements, it might be a good idea to discuss your medications with the study 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. Studies have linked higher UPF intake to an increased risk of type 2 diabetes and heart problems. Specifically, increasing UPF consumption by 10% raises the risk of metabolic syndrome, which can lead to heart disease and diabetes, by 4%. UPFs often contain high levels of sugar and unhealthy fats, which can damage heart and overall health.

In contrast, direct evidence from trials on the safety of minimally processed foods (MPFs) is limited. However, MPFs are generally considered healthier. They resemble the foods our ancestors ate and typically contain less added sugar, salt, and unhealthy fats.

Overall, while UPFs may pose health risks, consuming more MPFs is often seen as a better choice for maintaining health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different types of food processing affect metabolic health. Unlike traditional dietary studies that might focus on calorie counting or specific nutrients, this trial examines the metabolic effects of ultra-processed versus minimally processed foods using the NOVA scale. By measuring glucose, insulin, and metabolic rates in a controlled setting, researchers aim to uncover how the degree of food processing influences our bodies' responses. This could lead to a better understanding of how food choices impact health beyond just calorie content or macronutrient composition.

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

This trial will compare the effects of ultra-processed foods (UPFs) and minimally processed foods on metabolic health. Studies have shown that UPFs are linked to worse health outcomes, such as heart problems and other long-term diseases. Research indicates that these foods can cause larger spikes in blood sugar and insulin levels after eating, potentially leading to more cravings and quicker hunger, which may result in increased food intake. Conversely, minimally processed foods, which participants in this trial may receive, tend to have a more stable and balanced effect on the body. Early findings suggest that meals with fewer additives and less processing may better control appetite and support healthier bodily responses. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with a BMI of 18.5-24.9, living near Roanoke, who can see a computer screen clearly and are not pregnant. Excluded are those with MRI contraindications like pacemakers, metal implants, claustrophobia; history of significant head injury; metabolic disorders including diabetes or thyroid issues; substance dependence; active neurological conditions; eating disorders or food allergies.

Inclusion Criteria

Residing in the Roanoke area and/or willing/able to attend sessions at the Fralin Biomedical Research Institute

Your weight is considered normal for your height.

Able to speak and write in English

Exclusion Criteria

Contraindications to MRI: Individuals with pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants

I have had a head injury that made me unconscious for over 10 minutes.

I have or had diabetes or a thyroid condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Participants undergo baseline measurements in a whole room metabolic chamber for 45 minutes before meal consumption

45 minutes

Multiple visits (in-person)

Treatment

Participants consume meals containing either minimally or ultra-processed foods, with metabolic responses measured for 3 hours post-consumption

3 hours per session

Multiple visits (in-person)

Auction Task

Participants undergo a Becker-Degroot-Marschak auction paradigm in an MRI scanner to assess food value and neural responses

3 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Minimally Processed Food - Additives Meal
• Minimally Processed Food - Ingredients Meal
• Minimally Processed Food - Picture Set Meal
• Ultra-processed food - Additives Meal
• Ultra-processed food - Ingredients Meal
• Ultra-processed food - Picture Set Meal

Trial Overview

The study compares the body's response to minimally processed foods (MPFs) versus ultra-processed foods (UPFs). Participants will eat meals from both categories in a controlled setting while their metabolic responses are measured. They'll also bid on these foods in an MRI scanner to assess brain activity related to food value perception.

How Is the Trial Designed?

Group I: Stimulus: UPF3 Experimental Treatment 6 Interventions

In a whole room metabolic chamber participants will consume a \~300 kcal meal consisting of ultra-processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).

Group II: Stimulus: UPF2 Experimental Treatment 6 Interventions

In a whole room metabolic chamber participants will consume a \~300 kcal meal consisting of ultra-processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).

Group III: Stimulus: UPF1 Experimental Treatment 6 Interventions

In a whole room metabolic chamber participants will consume a \~300 kcal meal consisting of ultra-processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).

Group IV: Stimulus: MPF1 Active Control 6 Interventions

In a whole room metabolic chamber participants will consume a \~300 kcal meal consisting of minimally processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).

Group V: Stimulus: MPF3 Active Control 6 Interventions

In a whole room metabolic chamber participants will consume a \~300 kcal meal consisting of minimally processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).

Group VI: Stimulus: MPF2 Active Control 6 Interventions

In a whole room metabolic chamber participants will consume a \~300 kcal meal consisting of minimally processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Published Research Related to This Trial

The study found that hospital menus contained 25.2% of energy from ultra-processed foods (UPF), which are linked to lower nutrient density, highlighting a potential issue in hospital nutrition.

In contrast, minimally processed foods (MPF) and processed culinary ingredients (PCI) were associated with higher energy, protein, and essential micronutrients, suggesting that increasing these foods in hospital diets could help combat malnutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How processed is the hospital menu? An analysis based on NOVA food scoring system. Detopoulou, P., Panoutsopoulos, GI.[2023]

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]

A review of 43 studies found that 37 studies linked ultra-processed food (UPF) consumption to various adverse health outcomes, including obesity, type-2 diabetes, and cardiovascular diseases in adults, and cardio-metabolic risks in children.

No studies reported any beneficial health outcomes associated with UPF consumption, highlighting the need for dietary guidelines that consider the health risks of these foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Foods and Health Outcomes: A Narrative Review. Elizabeth, L., Machado, P., Zinöcker, M., et al.[2021]

Ultra-processed food (UPF) consumption is linked to a higher risk of weight gain and related health issues in both adults and children, based on observational studies.

A mechanistic study indicates that UPFs lead to greater energy intake and weight gain compared to whole foods, suggesting that reducing UPF consumption could improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-processed Foods, Weight Gain, and Co-morbidity Risk. Crimarco, A., Landry, MJ., Gardner, CD.[2022]

Higher intake of unprocessed and minimally processed foods (UMP) is linked to improved diet quality metrics over 3 decades in two large cohorts of health professionals, with significant increases in scores for healthy eating indices.

In contrast, higher consumption of ultraprocessed foods (UPF) is associated with lower diet quality, indicating that UMP consumption promotes healthier eating patterns while UPF consumption detracts from them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intakes of Unprocessed and Minimally Processed and Ultraprocessed Food Are Associated with Diet Quality in Female and Male Health Professionals in the United States: A Prospective Analysis. Rossato, SL., Khandpur, N., Lo, CH., et al.[2023]

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]

The semi-quantitative food frequency questionnaire (SFFQ) demonstrated acceptable validity in estimating energy intake from both unprocessed/minimally processed foods and ultra-processed foods among 226 Mexican adults, regardless of age group.

Correlation coefficients indicated a stronger relationship for ultra-processed foods (0.67 for adults <60 years and 0.48 for adults ≥60 years) compared to unprocessed/minimally processed foods, suggesting that the SFFQ is particularly effective for assessing intake of ultra-processed foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Semi-quantitative Food Frequency Questionnaire Has Relative Validity to Identify Groups of NOVA Food Classification System Among Mexican Adults. Oviedo-Solís, CI., Monterrubio-Flores, EA., Rodríguez-Ramírez, S., et al.[2022]

The concept of 'ultra-processed food' (UPF) is debated among experts, with concerns about its definitions and the lack of clear evidence linking processing to poor health outcomes, suggesting that public health messages should focus on reducing high fat, sugar, and salt intake instead.

Experts warn that advising people to avoid UPF could lead to stigma and confusion, especially for vulnerable groups, as some UPF items are affordable sources of essential nutrients, indicating a need for practical guidance on healthier food choices rather than outright avoidance of UPF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do we differentiate not demonise - Is there a role for healthier processed foods in an age of food insecurity? Proceedings of a roundtable event. Lockyer, S., Spiro, A., Berry, S., et al.[2023]

Recent research, including 30 studies, indicates that high consumption of ultra-processed foods (UPF) is linked to negative effects on metabolic health, such as increased risk of metabolic syndrome, obesity, and cardiovascular diseases.

The evidence suggests a strong need to reduce UPF consumption globally, especially among adults, although further studies are required to establish clear causal relationships and understand the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of ultra-processed food consumption on metabolic health. Costa de Miranda, R., Rauber, F., Levy, RB.[2021]

In a study of 962 Chilean preschoolers, using different methods to define ultra-processed foods (UPF) revealed that the proportion of UPF in their diets ranged from 65% to 73%, depending on the method used, indicating that the definition significantly impacts dietary assessments.

The method that included all possible ingredient markers and cosmetic additives identified a higher caloric share of UPF (58%) in preschoolers' diets compared to the classic method (47%), highlighting the importance of comprehensive definitions in dietary policy and health assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the use of food ingredients and additives on the estimation of ultra-processed foods and beverages. Zancheta Ricardo, C., Duran, AC., Grilo, MF., et al.[2023]

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