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

Trial Summary

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.

What data supports the effectiveness of the treatment Minimally Processed Food for Metabolic Health?

Research indicates that diets high in unprocessed and minimally processed foods are linked to better diet quality, while ultra-processed foods are associated with poor diet quality and higher risks of chronic diseases like obesity and type-2 diabetes. ^{1 2 3 4 5}

Is it safe to consume minimally processed foods compared to ultra-processed foods?

Minimally processed foods are generally considered safer and healthier than ultra-processed foods, which have been linked to various health risks like obesity, type-2 diabetes, and cardiovascular diseases. Public health authorities recommend limiting ultra-processed foods due to their potential adverse effects. ^{1 2 3 6 7}

How does the treatment of processed vs minimally processed foods differ from other treatments for metabolic health?

This treatment is unique because it focuses on the type and extent of food processing rather than specific nutrients or medications. It compares the effects of minimally processed foods, which are closer to their natural state, with ultra-processed foods, which are heavily modified and often contain added sugars, fats, and salts, on metabolic health. ^{1 3 8 9 10}

What is the purpose of this trial?

The minimally processed diets of our ancestors have been rapidly replaced by UPFs driving poor diet to become the leading risk factor for preventable death globally. Hence, it is essential to understand what properties of UPF are driving their overconsumption to reduce diet-related mortality. To address this gap in knowledge this proposal will test: * If UPFs have a greater post meal metabolic response when compared to MPFs an essential signal for food reward * Through the use of an auction task paradigm if UPFs overvalued and if this value is differentially encoded in the brain This study is a fully cross-over design in that each participant receives all conditions and therefore serves as their own control. All orders of foods will be counterbalanced. Although participants cannot be blinded to the conditions as they must be aware of the foods they are eating, they will not be made aware that the key manipulation is food processing. On different days participants will come to the lab and consume a meal containing either minimally or ultra-processed foods as determined by the widely used NOVA (not an acronym) scale. These conditions will be consumed in a whole room metabolic chamber allowing for simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). These measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial). All participants will also undergo a Becker-Degroot-Marschak auction paradigm that consists of foods that are either minimally or Ultra-processed in the MRI scanner. Food value will be measure in participants' willingness to pay for each food and Neural responses will be measured during presentation of the food cues.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Ultra-processed food : from research to guidelines]. [2022]

3. England pubmed.ncbi.nlm.nih.gov

How processed is the hospital menu? An analysis based on NOVA food scoring system. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Ultra-processed Foods, Weight Gain, and Co-morbidity Risk. [2022]

5. United States 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of the use of food ingredients and additives on the estimation of ultra-processed foods and beverages. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Ultra-Processed Foods and Health Outcomes: A Narrative Review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Impact of ultra-processed food consumption on metabolic health. [2021]

9. Switzerland 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. [2022]

10. England 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. [2023]