Young Adult Eating Habits (YAEH)

July 8, 2026 updated by: Alexandra DiFeliceantonio, Virginia Polytechnic Institute and State University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Brenda M Davy, PhD, RDN
  • Phone Number: 540-231-6784
  • Email: davy@vt.edu

Study Contact Backup

  • Name: Alexandra G DiFeliceantonio, PhD
  • Phone Number: 540-526-2285
  • Email: dife@vt.edu

Study Locations

  • United States
    • Virginia
      • Blacksburg, Virginia, United States, 24061
        • Virginia Polytechnic Institute and State University
      • Roanoke, Virginia, United States, 24016
        • Fralin Biomedical Research Institute at VTC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)
  • No reported history of eating disorders
  • Sedentary to recreationally active
  • ADHD medications if same med >3 months at time of study

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High Ultra Processed Food Diet
Participants will consume a diet containing 81% total energy from UPF for 2 weeks.
Other: High Ultra Processed Food Diet
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.
Experimental: No Ultra Processed Food Diet
Participants will consume a diet containing 0% total energy from UPF for 2 weeks.
Other: No Ultra Processed Food Diet
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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.
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)
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
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)
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.
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)
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.
2 measurements (once following the 2-week UPF diet, once following the 2-week no UPF diet)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Executive Function From Baseline to 2-weeks Post High UPF or 2 Weeks no UPF Diet
Time Frame: 2 measurements (post minus pre 2-week UPF diet, post minus pre 2-week no UPF diet)
Participants will undergo computerized tests of executive function, such as working memory, cognitive flexibility, and inhibitory control. These tasks have been widely used with participants across the lifespan and contain simple graphics. The task used was Corsi backward block-tapping test measuring working memory. The score (1-9), or level for each participant was measured by the longest sequence length a participant can successfully reproduce, with higher level suggesting stronger visuospatial working memory capacity.
2 measurements (post minus pre 2-week UPF diet, post minus pre 2-week no UPF diet)
Energy Intake (kcal) in the Absence of Hunger Following the 2-weeks Post High UPF or 2 Weeks no UPF Diet
Time Frame: 2 measurements (in person following the 2-week UPF diet, in person following the 2-week no UPF diet)
Following the ad libitum buffet meal, participants will move to a separate room where an ample amount of 6 pre-weighed snack items (3 UPF, 3 no UPF) and magazines are available. Using an approach consistent with previous research studying this outcome, participants will be instructed to take 2 bites of each snack item and rate its palatability on the LHS, and to eat the remainder of the snacks or look at the magazines while they wait for the next part of the study. Participants will be left to consume the snacks or relax for 15 minutes. Participants will also be given a box of snacks to assess eating in the absence of hunger outside the laboratory environment. Snack boxes will be returned to study staff the next morning. Staff will document the amount and type of snacks consumed.
2 measurements (in person following the 2-week UPF diet, in person following the 2-week no UPF diet)
Change in Hunger Ratings From 2 Weeks High UPF or 2 Weeks no UPF Diet
Time Frame: 2 measurements (once following the 2-week UPF diet, once following the 2-week no UPF diet)
To assess sensations of hunger a Visual Analog Scale bounded by "Not hungry at all" numerically represented as 0 (Minimum) and "Very hungry" numerically represented as 100 (Maximum) will be used. For the Visual Analog Scale, higher scores indicate higher hunger and lower scores indicate lower hunger. Visual Analog Scales (VAS) will be completed immediately prior to buffet meal and immediately following buffet meal completion, following the 2-week UPF diet and 2-week no UPF diet.
2 measurements (once following the 2-week UPF diet, once following the 2-week no UPF diet)
Change in Sensitivity to Delayed Reward From Baseline to Following 2 Weeks High UPF or 2 Weeks no UPF Diet
Time Frame: 2 measurements (post minus pre 2-week UPF diet, post minus pre 2-week no UPF diet)
To assess sensitivity to delayed reward by assessing preference for different amounts of money varying over different amounts of time. This will be associated with a k value (discount rate), the lower the k value, the less discounting.
2 measurements (post minus pre 2-week UPF diet, post minus pre 2-week no UPF diet)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Polytechnic Institute and State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandra G DiFeliceantonio, PhD, Virginia Polytechnic Institute and State University
  • Principal Investigator: Brenda M Davy, PhD, RDN, Virginia Polytechnic Institute and State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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