NCT06017986

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2023Jul 2026

Study Start

First participant enrolled

July 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

3 years

First QC Date

August 1, 2023

Last Update Submit

June 10, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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 (for 45 minutes) and for 3 hours after consumption of each condition on different days.

    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 (for 45 minutes) and for 3 hours after consumption of each condition on different days.

    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 (for 45 minutes) and for 3 hours after consumption of each condition on different days.

    Immediately post intervention

  • Effect of food processing on food value and encoding

    A food picture set of 28 that are matched on 23 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.

    through study completion, an average of 3 weeks

Study Arms (6)

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).

Other: Ultra-processed food - Picture Set MealOther: Ultra-processed food - Additives MealOther: Ultra-processed food - Ingredients MealOther: Minimally Processed Food - Picture Set MealOther: Minimally Processed Food - Additives MealOther: Minimally Processed Food - Ingredients Meal

Stimulus: UPF2

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).

Other: Ultra-processed food - Picture Set MealOther: Ultra-processed food - Additives MealOther: Ultra-processed food - Ingredients MealOther: Minimally Processed Food - Picture Set MealOther: Minimally Processed Food - Additives MealOther: Minimally Processed Food - Ingredients Meal

Stimulus: UPF3

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).

Other: Ultra-processed food - Picture Set MealOther: Ultra-processed food - Additives MealOther: Ultra-processed food - Ingredients MealOther: Minimally Processed Food - Picture Set MealOther: Minimally Processed Food - Additives MealOther: Minimally Processed Food - Ingredients 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).

Other: Ultra-processed food - Picture Set MealOther: Ultra-processed food - Additives MealOther: Ultra-processed food - Ingredients MealOther: Minimally Processed Food - Picture Set MealOther: Minimally Processed Food - Additives MealOther: Minimally Processed Food - Ingredients Meal

Stimulus: MPF2

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).

Other: Ultra-processed food - Picture Set MealOther: Ultra-processed food - Additives MealOther: Ultra-processed food - Ingredients MealOther: Minimally Processed Food - Picture Set MealOther: Minimally Processed Food - Additives MealOther: Minimally Processed Food - Ingredients Meal

Stimulus: MPF3

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).

Other: Ultra-processed food - Picture Set MealOther: Ultra-processed food - Additives MealOther: Ultra-processed food - Ingredients MealOther: Minimally Processed Food - Picture Set MealOther: Minimally Processed Food - Additives MealOther: Minimally Processed Food - Ingredients Meal

Interventions

A meal containing ultra-processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.

Stimulus: MPF1Stimulus: MPF2Stimulus: MPF3Stimulus: UPF1Stimulus: UPF2Stimulus: UPF3

A meal containing ultra-processed foods that very on degree of additives.

Stimulus: MPF1Stimulus: MPF2Stimulus: MPF3Stimulus: UPF1Stimulus: UPF2Stimulus: UPF3

a meal containing ultra-processed foods that very on degree of processing but not ingredients.

Stimulus: MPF1Stimulus: MPF2Stimulus: MPF3Stimulus: UPF1Stimulus: UPF2Stimulus: UPF3

a meal containing minimally processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.

Stimulus: MPF1Stimulus: MPF2Stimulus: MPF3Stimulus: UPF1Stimulus: UPF2Stimulus: UPF3

A meal containing minimally processed foods that very on degree of additives.

Stimulus: MPF1Stimulus: MPF2Stimulus: MPF3Stimulus: UPF1Stimulus: UPF2Stimulus: UPF3

A meal containing minimally processed foods that very on degree of processing but not ingredients.

Stimulus: MPF1Stimulus: MPF2Stimulus: MPF3Stimulus: UPF1Stimulus: UPF2Stimulus: UPF3

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Claustrophobia (this would make lying in an MRI scanner or indirect calorimetry canopy very uncomfortable).
  • \. 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.
  • \. History of alcohol or drug dependence 6. Active neurologic disorder 8. Diagnosed eating disorder 9. Food allergies or restrictive diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Central Study Contacts

Alexandra G DiFeliceantonio, PhD

CONTACT

Zach Hutelin

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 30, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations