Eating BehaviorYAEHNCT05550818
Young Adult Eating Habits
A study testing High Ultra Processed Food Diet and No Ultra Processed Food Diet in people with Eating Behavior and Eating Habit, run by Virginia Polytechnic Institute and State University at 2 sites in United States.
Trial summary
Most individuals with obesity become so before age 35 and adolescent's unhealthy dietary patterns, specifically high intake of ultra-processed foods and poor overall diet quality, may contribute to energy overconsumption and weight gain. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Eating Habit
- What is being tested?
- High Ultra Processed Food Diet and No Ultra Processed Food Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Mar 2023to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-25 years
- Weight stable (+5 lbs) for previous 6 months
- No plans to gain/lose weight or change physical activity level
- Willing to pick up food daily and consume foods provided for two 14-day periods
- Verbal and written informed consent
- Unrestrained eater (TFEQ cognitive restraint score <11)
Show all 9Show fewer
- No reported history of eating disorders
- Sedentary to recreationally active
- ADHD medications if same med >3 months at time of study
Who cannot join
- BMI >30 kg/m2
- Endocrine disorders or other major chronic disease (e.g., type 2 diabetes, hypothyroidism, hypertension)
- Pregnant or plans to become pregnant
- Food allergies or aversions
- Claustrophobia
- History of head injury with loss of consciousness for more than 10 minutes
- Contraindications to MRI: individuals with pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, 24061
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Official title: Influence of Ultra-processed Foods on Reward Processing and Energy Intake
Most individuals with obesity become so before age 35 and adolescent's unhealthy dietary patterns, specifically high intake of ultra-processed foods and poor overall diet quality, may contribute to energy overconsumption and weight gain. The overall objective of this research is to establish proof-of-concept for altered reward processing measured by brain response to ultra-processed foods, an increase in ad libitum energy intake, and adverse effects on executive function in response to an ultra-processed diet (81% total energy) compared to a diet emphasizing minimally processed foods in individuals aged 18-25 years.
Read the detailed description
Most individuals with obesity become so before age 35. In the US population, adolescents have the highest ultra- processed food consumption (68% of total energy) and the lowest diet quality. Given that ultra-processed foods represent two-thirds of the energy consumed by adolescents and young adults, research is needed to understand the influence of food processing on eating behaviors, particularly in the late adolescence and early adulthood life stage. During this time, individuals have increasing independence in food choice and it represents a key developmental period for executive function, processes that affect life-long mental and physical health. Evidence from pre-clinical studies demonstrates rodents maintained on a "cafeteria diet" comprised of ultra- processed ingredients have greater energy intake, weight gain, and alterations in brain circuitry that regulates both energy intake and executive function than those exposed to a standard diet. However, the impact of ultra- processed foods on the brain circuits underlying reward processing, food intake regulation, food choice, and executive function in humans is unknown. Controlled diet interventions are needed to fill this void. The overall objective of this research is to establish proof-of-concept for altered reward processing measured by brain response to an ultra-processed milkshake, an increase in ad libitum energy intake in a buffet meal, and adverse effects on executive function in response to a diet high in ultra-processed foods (81% total energy) compared to a diet emphasizing un/minimally-processed foods in individuals aged 18-25 years. To address our objective, 32 individuals aged 18-25 years (late adolescence/early adulthood) (BMI<30) will undergo two 14-day controlled feeding conditions in a randomly assigned order. Diets will match the caloric needs of the individual and be matched for potential confounding factors including macronutrients, fiber, and energy density. To assess changes in reward processing, brain response to an ultra-processed milkshake will be assessed via functional magnetic resonance imaging before and after each feeding period (4 measurements). Measurements immediately following each feeding period will include ad libitum energy intake and food selection at a breakfast buffet meal (containing both ultra-processed and minimally processed foods), eating in the absence of hunger post-meal, and executive function. Although consumption of ultra-processed foods may contribute to dysregulation of energy intake, mechanisms are uncertain and existing dietary guidelines do not address ultra- processed food intake due to a lack of human experimental research. The proposed research could address this gap and inform dietary guidelines for individuals at a critical developmental life stage - late adolescence to early adulthood.
- Conditions
- Eating Behavior, Eating Habit
- Being tested
- High Ultra Processed Food Diet, No Ultra Processed Food Diet
- Keywords
- Ultra-processed food, Minimally-processed food, Executive Functioning, Eating Habits, Reward Sensitivity, Brain Activity, fMRI
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Ultra Processed Food DietOther
Participants will be provided and consume a diet emphasizing UPF (81% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.
No Ultra Processed Food DietOther
Participants will be provided and consume a diet containing no UPF (0% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Ultra Processed Food Diet | Experimental | Participants will consume a diet containing 81% total energy from UPF for 2 weeks. Receives: Other: High Ultra Processed Food Diet |
| No Ultra Processed Food Diet | Experimental | Participants will consume a diet containing 0% total energy from UPF for 2 weeks. Receives: Other: No Ultra Processed Food Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brain Response From Baseline to 2-weeks Post High UPF or 2 Weeks no UPF Diet
Brain response to milkshake was measured using functional magnetic resonance imaging (fMRI). On the first level a contrast of milkshake > tasteless was built. The measures presented here are the beta values of the milkshake>tasteless contrast extracted from an orbital frontal cortex apriori region of interest. The pre intervention beta values were subtracted from the post intervention values. Extracted beta values are by definition arbitrary units and are the standard measure for fMRI.
Measured: 4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)
Secondary outcomes (5)
Energy Intake (Total Kcals Consumed) After 2 Weeks High UPF or 2 Weeks no UPF Diet
Participants will arrive at the laboratory in the fasted state for an ad libitum breakfast buffet meal. The buffet meal will contain a variety of food items that vary in macronutrient content and in their degree of processing (UPF, no UPF). The meal will consist of typical breakfast items in excess of what would normally be consumed. Participants will self-select foods over a 30-minute period. Food items will be weighed (±0.1 grams) prior to and after the completion of the meal to determine the amount consumed (g, kcal), calculated using NDSR nutritional analysis software.
Measured: 2 measurements total following the 2-week UPF diet (day 15) and following the 2-week no UPF diet (day 15)
Eating Rate (kcal Per Minute) After 2 Weeks High UPF or 2 Weeks no UPF Diet
Participants will arrive at the laboratory in the fasted state for an ad libitum breakfast buffet meal. The buffet meal will contain a variety of food items that vary in macronutrient content and in their degree of processing (UPF, no UPF). The meal will consist of typical breakfast items in excess of what would normally be consumed. Participants will self-select foods over a 30-minute period. Meal eating rate (g/min, kcal/min) will be determined using meal start and stop times.
Measured: 2 measurements total following the 2-week UPF diet (day 15) and following the 2-week no UPF diet (day 15)
Number of UPF Food Items Selected After 2 Weeks High UPF or 2 Weeks no UPF Diet
At the ad libitum buffet meal following the 2-week UPF diet and 2-week no UPF diet, food selection will be determined by the number of items consumed from UPF
Measured: 2 measurement (once following the 2-week UPF diet, once following the 2-week no UPF diet)
Change in Grams of UPF vs no UPF Food Items Selected After 2 Weeks High UPF or 2 Weeks no UPF Diet in the ad Libitum Buffet Meal Task
At the ad libitum buffet meal following the 2-week UPF diet and 2-week no UPF diet, food selection will be determined by the number of grams consumed from UPF minus no UPF food items. For both diet interventions, all buffet food items are weighed before and after the task to calculated change in grams of UPF minus no UPF food items selected.
Measured: 2 measurements (once following the 2-week UPF diet, once following the 2-week no UPF diet)
Change in Amount of Energy (Kcals) Selected From UPF vs no UPF Food Items After 2 Weeks High UPF or 2 Weeks no UPF Diet in the ad Libitum Buffet Meal Task
At the ad libitum buffet meal following the 2-week UPF diet and 2-week no UPF diet, food selection will be determined by the number of amount of energy (kcals) consumed from UPF minus no UPF. For both diet interventions, all buffet food items are weighed before and after the task to calculated change in energy (kcals) of UPF minus no UPF food items selected.
Measured: 2 measurements (once following the 2-week UPF diet, once following the 2-week no UPF diet)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start10 Mar 2023
- Primary completion15 Dec 2024
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra DiFeliceantonio, Virginia Polytechnic Institute and State University
- Investigators
- Alexandra G DiFeliceantonio, PhD, Principal investigator, Virginia Polytechnic Institute and State UniversityBrenda M Davy, PhD, RDN, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550818
- Sponsor's protocol ID
- 22-253
- Acronym
- YAEH
- Status last verified
- Jul 2026
- First submitted
- 9 Sep 2022
- Last updated
- 8 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rego MLM, Leslie E, Schmall E, Capra B, Hudson S, Ahrens ML, Katz B, Davy KP, Hedrick VE, DiFeliceantonio AG, Davy BM. The Influence of Ultraprocessed Food Consumption on Energy Intake in Emerging Adulthood: A Controlled Feeding Trial. Obesity (Silver Spring). 2026 Feb;34(2):344-356. doi: 10.1002/oby.70086. Epub 2025 Nov 19.
PubMed 41255123
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Ultra-processed Foods on Reward Processing and Energy Intake
- ClinicalTrials.gov ID
- NCT05550818
- Acronym / sponsor ID
- YAEH / 22-253
- Conditions
- Eating Behavior, Eating Habit
- Keywords
- Ultra-processed food, Minimally-processed food, Executive Functioning, Eating Habits, Reward Sensitivity, Brain Activity, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Posted 12 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most individuals with obesity become so before age 35 and adolescent's unhealthy dietary patterns, specifically high intake of ultra-processed foods and poor overall diet quality, may contribute to energy overconsumption and weight gain. The overall objective of this research is to establish proof-of-concept for altered reward processing measured by brain response to ultra-processed foods, an increase in ad libitum energy intake, and adverse effects on executive function in response to an ultra-processed diet (81% total energy) compared to a diet emphasizing minimally processed foods in individuals aged 18-25 years.
Detailed description
Most individuals with obesity become so before age 35. In the US population, adolescents have the highest ultra- processed food consumption (68% of total energy) and the lowest diet quality. Given that ultra-processed foods represent two-thirds of the energy consumed by adolescents and young adults, research is needed to understand the influence of food processing on eating behaviors, particularly in the late adolescence and early adulthood life stage. During this time, individuals have increasing independence in food choice and it represents a key developmental period for executive function, processes that affect life-long mental and physical health. Evidence from pre-clinical studies demonstrates rodents maintained on a "cafeteria diet" comprised of ultra- processed ingredients have greater energy intake, weight gain, and alterations in brain circuitry that regulates both energy intake and executive function than those exposed to a standard diet. However, the impact of ultra- processed foods on the brain circuits underlying reward processing, food intake regulation, food choice, and executive function in humans is unknown. Controlled diet interventions are needed to fill this void. The overall objective of this research is to establish proof-of-concept for altered reward processing measured by brain response to an ultra-processed milkshake, an increase in ad libitum energy intake in a buffet meal, and adverse effects on executive function in response to a diet high in ultra-processed foods (81% total energy) compared to a diet emphasizing un/minimally-processed foods in individuals aged 18-25 years. To address our objective, 32 individuals aged 18-25 years (late adolescence/early adulthood) (BMI<30) will undergo two 14-day controlled feeding conditions in a randomly assigned order. Diets will match the caloric needs of the individual and be matched for potential confounding factors including macronutrients, fiber, and energy density. To assess changes in reward processing, brain response to an ultra-processed milkshake will be assessed via functional magnetic resonance imaging before and after each feeding period (4 measurements). Measurements immediately following each feeding period will include ad libitum energy intake and food selection at a breakfast buffet meal (containing both ultra-processed and minimally processed foods), eating in the absence of hunger post-meal, and executive function. Although consumption of ultra-processed foods may contribute to dysregulation of energy intake, mechanisms are uncertain and existing dietary guidelines do not address ultra- processed food intake due to a lack of human experimental research. The proposed research could address this gap and inform dietary guidelines for individuals at a critical developmental life stage - late adolescence to early adulthood.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Ultra Processed Food Diet | Experimental | Other: High Ultra Processed Food DietParticipants will consume a diet containing 81% total energy from UPF for 2 weeks. |
| No Ultra Processed Food Diet | Experimental | Other: No Ultra Processed Food DietParticipants will consume a diet containing 0% total energy from UPF for 2 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-25 years
- Weight stable (+5 lbs) for previous 6 months
- No plans to gain/lose weight or change physical activity level
- Willing to pick up food daily and consume foods provided for two 14-day periods
- Verbal and written informed consent
Key exclusion criteria (7 listed)
- BMI >30 kg/m2
- Endocrine disorders or other major chronic disease (e.g., type 2 diabetes, hypothyroidism, hypertension)
- Pregnant or plans to become pregnant
- Food allergies or aversions
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Ultra Processed Food DietParticipants will be provided and consume a diet emphasizing UPF (81% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks. | Other | High Ultra Processed Food Diet |
| No Ultra Processed Food DietParticipants will be provided and consume a diet containing no UPF (0% energy). Diets will be eucaloric (50% carbohydrate, 35% fat,15% protein) matched for dietary soluble and insoluble fiber, added sugar, mono- and polyunsaturated fat, saturated fat, antioxidant nutrients, sodium, and overall diet quality, for 2 weeks. | Other | No Ultra Processed Food Diet |
Primary outcome
Change in Brain Response From Baseline to 2-weeks Post High UPF or 2 Weeks no UPF Diet
Time frame: 4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)
Brain response to milkshake was measured using functional magnetic resonance imaging (fMRI). On the first level a contrast of milkshake > tasteless was built. The measures presented here are the beta values of the milkshake>tasteless contrast extracted from an orbital frontal cortex apriori region of interest. The pre intervention beta values were subtracted from the post intervention values. Extracted beta values are by definition arbitrary units and are the standard measure for fMRI.
5 secondary outcomes
Energy Intake (Total Kcals Consumed) After 2 Weeks High UPF or 2 Weeks no UPF Diet
Time frame: 2 measurements total following the 2-week UPF diet (day 15) and following the 2-week no UPF diet (day 15)
Eating Rate (kcal Per Minute) After 2 Weeks High UPF or 2 Weeks no UPF Diet
Time frame: 2 measurements total following the 2-week UPF diet (day 15) and following the 2-week no UPF diet (day 15)
Number of UPF Food Items Selected After 2 Weeks High UPF or 2 Weeks no UPF Diet
Time frame: 2 measurement (once following the 2-week UPF diet, once following the 2-week no UPF diet)
Change in Grams of UPF vs no UPF Food Items Selected After 2 Weeks High UPF or 2 Weeks no UPF Diet in the ad Libitum Buffet Meal Task
Time frame: 2 measurements (once following the 2-week UPF diet, once following the 2-week no UPF diet)
Change in Amount of Energy (Kcals) Selected From UPF vs no UPF Food Items After 2 Weeks High UPF or 2 Weeks no UPF Diet in the ad Libitum Buffet Meal Task
Time frame: 2 measurements (once following the 2-week UPF diet, once following the 2-week no UPF diet)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41255123Rego MLM, Leslie E, Schmall E, Capra B, Hudson S, Ahrens ML, Katz B, Davy KP, Hedrick VE, DiFeliceantonio AG, Davy BM. The Influence of Ultraprocessed Food Consumption on Energy Intake in Emerging Adulthood: A Controlled Feeding Trial. Obesity (Silver Spring). 2026 Feb;34(2):344-356. doi: 10.1002/oby.70086. Epub 2025 Nov 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra G DiFeliceantonio, PhD principal investigator
Virginia Polytechnic Institute and State University
Brenda M Davy, PhD, RDN principal investigator
Virginia Polytechnic Institute and State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Ultra Processed Food Diet and No Ultra Processed Food Diet in people with Eating Behavior and Eating Habit, run by Virginia Polytechnic Institute and State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain Response From Baseline to 2-weeks Post High UPF or 2 Weeks no UPF Diet (time frame: 4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05550818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.