The Effect of Processing on Food Reward

Metabolic Diseases Clinical Trial

— PFR  

Official title:

Metabolic and Physiological Effects of Processing on Food Reward Encoding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06017986
• Other study ID #: 21-1052
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: August 2023
• Source: Virginia Polytechnic Institute and State University
• Contact: Alexandra G DiFeliceantonio, PhD
• Phone: 5405262285
• Email: dife[@]vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Metabolic Diseases

Intervention

Other:
• Ultra-processed food - Picture Set Meal
A meal containing ultra-processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.
• Ultra-processed food - Additives Meal
A meal containing ultra-processed foods that very on degree of additives.
• Ultra-processed food - Ingredients Meal
a meal containing ultra-processed foods that very on degree of processing but not ingredients.
• Minimally Processed Food - Picture Set Meal
a meal containing minimally processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.
• Minimally Processed Food - Additives Meal
A meal containing minimally processed foods that very on degree of additives.
• Minimally Processed Food - Ingredients Meal
A meal containing minimally processed foods that very on degree of processing but not ingredients.

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute at VTC	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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