Clinical trial NCT06017986: The Effect of Processing on Food Reward
Official title: Metabolic and Physiological Effects of Processing on Food Reward Encoding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Diseases
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Blood glucose response to level of food processing
timeFrame: Immediately post intervention
measure: Blood insulin response to level of food processing
timeFrame: Immediately post intervention
measure: Energy expenditure in response to level of food processing
timeFrame: Immediately post intervention
measure: Respiratory exchange ratio in response to level of food processing
timeFrame: Immediately post intervention
measure: Substrate oxidation in response to level of food processing
timeFrame: Immediately post intervention
measure: Effect of food processing on food value and encoding
timeFrame: through study completion, an average of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at VTC
state: Virginia
Study officials:
References: