Metabolic DiseasesPFRNCT06017986
The Effect of Processing on Food Reward
A study testing Ultra-processed food - Picture Set Meal and Minimally Processed Food - Picture Set Meal in people with Metabolic Diseases, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases
- What is being tested?
- Ultra-processed food - Picture Set Meal and Minimally Processed Food - Picture Set Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 13 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self report BMI between 18.5-24.9 kg/m2
- Not pregnant or planning to become pregnant during study participation Residing in the Roanoke area and/or willing/able to attend sessions at the Fralin Biomedical Research Institute
- Able to speak and write in English
- Participants must be able to see a computer display clearly with or without vision correction (eyeglasses, contacts).
Who cannot join
- Claustrophobia (this would make lying in an MRI scanner or indirect calorimetry canopy very uncomfortable).
- 2. History of head injury resulting in loss of consciousness for more than 10 minutes 3. Current or past diagnosis of diabetes or metabolic disorder (thyroid disease, etc.) 4. Contraindications to MRI: Individuals with pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- 5. History of alcohol or drug dependence 6. Active neurologic disorder 8. Diagnosed eating disorder 9. Food allergies or restrictive diet
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Official title: Metabolic and Physiological Effects of Processing on Food Reward Encoding
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.
- Conditions
- Metabolic Diseases
- Being tested
- Ultra-processed food - Picture Set Meal, Minimally Processed Food - Picture Set Meal
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-processed food - Picture Set MealOther
A meal containing ultra-processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.
Minimally Processed Food - Picture Set MealOther
a meal containing minimally processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.
| Study group | Role | What they receive |
|---|---|---|
| Stimulus: UPF1 | Experimental | 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). Receives: Other: Ultra-processed food - Picture Set Meal; Other: Minimally Processed Food - Picture Set Meal |
| Stimulus: MPF1 | Active comparator | 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). Receives: Other: Ultra-processed food - Picture Set Meal; Other: Minimally Processed Food - Picture Set Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose response to level of food processing
Blood glucose concentration will be assessed at baseline and at set time points for 3 hours after consumption of each condition on different days.
Measured: Immediately post intervention
Blood insulin response to level of food processing
Blood insulin concentration will be assessed at baseline and at set time points for 3 hours after consumption of each condition on different days.
Measured: Immediately post intervention
Energy expenditure in response to level of food processing
Whole room indirect calorimetry will be used to determine energy expenditure at baseline and for 3 hours after consumption of each condition on different days.
Measured: Immediately post intervention
Respiratory exchange ratio in response to level of food processing
Whole room indirect calorimetry will be used to determine respiratory exchange ratio at baseline and for 3 hours after consumption of each condition on different days.
Measured: Immediately post intervention
Substrate oxidation in response to level of food processing
Whole room indirect calorimetry will be used to determine substrate oxidation at baseline and for 3 hours after consumption of each condition on different days.
Measured: Immediately post intervention
Effect of food processing on food value and encoding
A food picture set of 28 that are matched on 26 visual, perceptual, and nutritional properties but vary on degree of NOVA food processing level will be used in a Becker-Degroot-Marschak auction paradigm to assess participants' brain reward response for each food.
Measured: through study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Jul 2023
- Primary completion13 May 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra DiFeliceantonio, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017986
- Sponsor's protocol ID
- 21-1052
- Acronym
- PFR
- Status last verified
- May 2026
- First submitted
- 1 Aug 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Physiological Effects of Processing on Food Reward Encoding
- ClinicalTrials.gov ID
- NCT06017986
- Acronym / sponsor ID
- PFR / 21-1052
- Conditions
- Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulus: UPF1 | Experimental | Other: Ultra-processed food - Picture Set Meal, Other: Minimally Processed Food - Picture Set MealIn 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). |
| Stimulus: MPF1 | Active comparator | Other: Ultra-processed food - Picture Set Meal, Other: Minimally Processed Food - Picture Set MealIn 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 may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Self report BMI between 18.5-24.9 kg/m2
- Not pregnant or planning to become pregnant during study participation Residing in the Roanoke area and/or willing/able to attend sessions at the Fralin Biomedical Research Institute
- Able to speak and write in English
- Participants must be able to see a computer display clearly with or without vision correction (eyeglasses, contacts).
Key exclusion criteria (3 listed)
- Claustrophobia (this would make lying in an MRI scanner or indirect calorimetry canopy very uncomfortable).
- 2. History of head injury resulting in loss of consciousness for more than 10 minutes 3. Current or past diagnosis of diabetes or metabolic disorder (thyroid disease, etc.) 4. Contraindications to MRI: Individuals with pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- 5. History of alcohol or drug dependence 6. Active neurologic disorder 8. Diagnosed eating disorder 9. Food allergies or restrictive diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-processed food - Picture Set MealA meal containing ultra-processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm. | Other | Stimulus: MPF1, Stimulus: UPF1 |
| Minimally Processed Food - Picture Set Meala meal containing minimally processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm. | Other | Stimulus: MPF1, Stimulus: UPF1 |
Primary outcome
Blood glucose response to level of food processing
Time frame: Immediately post intervention
Blood glucose concentration will be assessed at baseline and at set time points for 3 hours after consumption of each condition on different days.
Blood insulin response to level of food processing
Time frame: Immediately post intervention
Blood insulin concentration will be assessed at baseline and at set time points for 3 hours after consumption of each condition on different days.
Energy expenditure in response to level of food processing
Time frame: Immediately post intervention
Whole room indirect calorimetry will be used to determine energy expenditure at baseline and for 3 hours after consumption of each condition on different days.
Respiratory exchange ratio in response to level of food processing
Time frame: Immediately post intervention
Whole room indirect calorimetry will be used to determine respiratory exchange ratio at baseline and for 3 hours after consumption of each condition on different days.
Substrate oxidation in response to level of food processing
Time frame: Immediately post intervention
Whole room indirect calorimetry will be used to determine substrate oxidation at baseline and for 3 hours after consumption of each condition on different days.
Effect of food processing on food value and encoding
Time frame: through study completion, an average of 3 weeks
A food picture set of 28 that are matched on 26 visual, perceptual, and nutritional properties but vary on degree of NOVA food processing level will be used in a Becker-Degroot-Marschak auction paradigm to assess participants' brain reward response for each food.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-processed food - Picture Set Meal and Minimally Processed Food - Picture Set Meal in people with Metabolic Diseases, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose response to level of food processing (time frame: Immediately post intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.