- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06017986
The Effect of Processing on Food Reward (PFR)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Fralin Biomedical Research Institute at VTC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stimulus: UPF1
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).
|
A meal containing ultra-processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.
a meal containing minimally processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.
|
|
Active Comparator: Stimulus: MPF1
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).
|
A meal containing ultra-processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.
a meal containing minimally processed foods derived from the picture set used in the Becker-Degroot-Marschak auction paradigm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately post intervention
|
|
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.
|
Immediately post intervention
|
|
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.
|
Immediately post intervention
|
|
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.
|
Immediately post intervention
|
|
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.
|
Immediately post intervention
|
|
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.
|
through study completion, an average of 3 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-1052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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