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The Effect of Processing on Food Reward (PFR)

Primary Purpose

Metabolic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultra-processed food - Picture Set Meal
Ultra-processed food - Additives Meal
Ultra-processed food - Ingredients Meal
Minimally Processed Food - Picture Set Meal
Minimally Processed Food - Additives Meal
Minimally Processed Food - Ingredients Meal
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Diseases

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fralin Biomedical Research Institute at VTCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Stimulus: UPF1

Stimulus: UPF2

Stimulus: UPF3

Stimulus: MPF1

Stimulus: MPF2

Stimulus: MPF3

Arm Description

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).

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).

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 1, 2023
Last Updated
August 24, 2023
Sponsor
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT06017986
Brief Title
The Effect of Processing on Food Reward
Acronym
PFR
Official Title
Metabolic and Physiological Effects of Processing on Food Reward Encoding
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Diseases

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimulus: UPF1
Arm Type
Experimental
Arm Description
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).
Arm Title
Stimulus: UPF2
Arm Type
Experimental
Arm Description
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).
Arm Title
Stimulus: UPF3
Arm Type
Experimental
Arm Description
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).
Arm Title
Stimulus: MPF1
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Stimulus: MPF2
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Stimulus: MPF3
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Ultra-processed food - Picture Set Meal
Intervention Description
A meal containing ultra-processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.
Intervention Type
Other
Intervention Name(s)
Ultra-processed food - Additives Meal
Intervention Description
A meal containing ultra-processed foods that very on degree of additives.
Intervention Type
Other
Intervention Name(s)
Ultra-processed food - Ingredients Meal
Intervention Description
a meal containing ultra-processed foods that very on degree of processing but not ingredients.
Intervention Type
Other
Intervention Name(s)
Minimally Processed Food - Picture Set Meal
Intervention Description
a meal containing minimally processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.
Intervention Type
Other
Intervention Name(s)
Minimally Processed Food - Additives Meal
Intervention Description
A meal containing minimally processed foods that very on degree of additives.
Intervention Type
Other
Intervention Name(s)
Minimally Processed Food - Ingredients Meal
Intervention Description
A meal containing minimally processed foods that very on degree of processing but not ingredients.
Primary Outcome Measure Information:
Title
Blood glucose response to level of food processing
Description
Blood glucose concentration will be assessed at baseline and at set time points for 3 hours after consumption of each condition on different days.
Time Frame
Immediately post intervention
Title
Blood insulin response to level of food processing
Description
Blood insulin concentration will be assessed at baseline and at set time points for 3 hours after consumption of each condition on different days.
Time Frame
Immediately post intervention
Title
Energy expenditure in response to level of food processing
Description
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.
Time Frame
Immediately post intervention
Title
Respiratory exchange ratio in response to level of food processing
Description
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.
Time Frame
Immediately post intervention
Title
Substrate oxidation in response to level of food processing
Description
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.
Time Frame
Immediately post intervention
Title
Effect of food processing on food value and encoding
Description
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.
Time Frame
through study completion, an average of 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra G DiFeliceantonio, PhD
Phone
5405262285
Email
dife@vt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Zach Hutelin
Email
hutelin@vt.edu
Facility Information:
Facility Name
Fralin Biomedical Research Institute at VTC
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra G DiFeliceantonio, PhD
Phone
540-526-2285
Email
dife@vt.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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