NCT05550818

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 12, 2026

Completed
Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

September 9, 2022

Results QC Date

November 24, 2025

Last Update Submit

December 18, 2025

Conditions

Keywords

Ultra-processed foodMinimally-processed foodExecutive FunctioningEating HabitsReward SensitivityBrain ActivityfMRI

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)

Secondary Outcomes (5)

  • Change in Energy Intake From 2 Weeks High UPF or 2 Weeks no UPF Diet

    2 measurements following the 2-week UPF diet (day 15), following the 2-week no UPF diet (day 15)

  • Change in Eating Rate From 2 Weeks High UPF or 2 Weeks no UPF Diet

    2 measurements following the 2-week UPF diet (day 15), following the 2-week no UPF diet (day 15)

  • Change in Food Items Selected From 2 Weeks High UPF or 2 Weeks no UPF Diet

    2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)

  • Change in Grams of Food Selected From 2 Weeks High UPF or 2 Weeks no UPF Diet

    2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)

  • Change in Amount of Energy (Kcals) Selected From 2 Weeks High UPF or 2 Weeks no UPF Diet

    2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)

Other Outcomes (4)

  • Change in Executive Function From Baseline to 2-weeks Post High UPF or 2 Weeks no UPF Diet

    4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)

  • Change in Eating in the Absence of Hunger From Baseline to 2-weeks Post High UPF or 2 Weeks no UPF Diet

    4 measurements (in person and take home portion following the 2-week UPF diet, in person and take home portion following the 2-week no UPF diet)

  • Change in Internal State Ratings From 2 Weeks High UPF or 2 Weeks no UPF Diet

    2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)

  • +1 more other outcomes

Study Arms (2)

High Ultra Processed Food Diet

EXPERIMENTAL

Participants will consume a diet containing 81% total energy from UPF for 2 weeks.

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.

Other: No Ultra Processed Food Diet

Interventions

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.

High 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.

No Ultra Processed Food Diet

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24061, United States

Location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Results Point of Contact

Title
Dr. Alexandra DiFeliceantonio
Organization
Virginia Tech

Study Officials

  • Alexandra G DiFeliceantonio, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR
  • Brenda M Davy, PhD, RDN

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants will be blind to what diet is being provided.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 22, 2022

Study Start

March 10, 2023

Primary Completion

December 15, 2024

Study Completion

June 10, 2025

Last Updated

January 12, 2026

Results First Posted

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations