NCT06165952

Brief Summary

Examine if ultra-processed (UP) foods are more effective in activating reward, attention, and memory brain regions and in promoting food cue learning than minimally-processed foods. Assess individual differences in neurobehavioral responses to UP foods.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Oct 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress42%
Oct 2024Feb 2029

First Submitted

Initial submission to the registry

December 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

October 4, 2024

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

December 1, 2023

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Body Fat

    Investigators will use air displacement plethysmography (ADP) via the Bod Pod and bioelectrical impedance (BIA) via the SECA medical body composition analyzer (SECA mBCA) to assess % body fat. The investigators will average the values of both measures. Body density is calculated as body mass divided by body volume; body density is used to calculate % body fat. ADP % body fat shows high test-retest reliability (r = .92-.99) and correlates with dual energy x-ray absorptiometry (DEXA) and hydrostatic weighing estimates (r = .98-.99), with ADP estimate of % body fat falling an average of only 1.7% different relative to DEXA estimates. Height will be measured using a direct reading stadiometer. Weight will be assessed using digital scales with participants wearing light clothing without shoes or coats. Body mass index (BMI)(Kg/M2) will be used to confirm participants are initially at a healthy weight (BMI scores between 25th to 75th age- and sex-adjusted BMI percentile).

    Baseline, 1-year, 2-year, 3-year, 4-year follow-up

  • Baseline functional magnetic resonance imaging (fMRI) Ultra-Processed Foods Taste, Anticipated Taste, and Picture Paradigm

    Participants will complete four rounds of an adapted version of a milkshake paradigm to assess activation in response to receipt (taste) and anticipated receipt of 1) high-calorie, ultra-processed food taste, 2) low-calorie, ultra-processed food taste, 3) high-calorie minimally-processed food taste, 4) low-calorie, minimally-processed food taste, and 5) a tasteless odorless solution containing the main ionic components of saliva. Participants will be cued with a picture of the specific food and label (high-calorie milkshake, low-calorie milkshake, high-calorie smoothie, low-calorie smoothie) before receipt of the tastes.

    Baseline

  • Baseline fMRI Ultra-Processed Food Picture Paradigm

    Participants will complete two rounds of a block version of the food picture paradigm to examine activation in response to 40 high-calorie ultra-processed food pictures, 40 low-calorie ultra-processed food pictures, 40 high-calorie minimally-processed food pictures, 40 low-calorie minimally-processed food pictures, and 40 bottles of water. Fifty percent of each category will be branded foods/bottles to increase ecological validity. Pictures will be matched for complexity, valence and intensity across categories. After the scan, participants will be shown 40 food pictures, including pictures that were and were not used in the paradigm, and will be asked whether they had seen the foods to assess aided recall. Participants will also be asked to rate palatability of 20 food pictures per food category.

    Baseline

  • Baseline fMRI Ultra-Processed Food Cue Learning Paradigm

    Participants will complete two rounds of an adapted version of the food reward learning paradigm wherein four arbitrary fractal cues will signal the delivery of either 0.7 ml of an ultra-processed milkshake, a minimally-processed smoothie, a tasteless solution, and no taste. To make learning more challenging, the paradigm includes both paired cue trials in which the taste is delivered as cued and unpaired cue trials in which the taste is not delivered at an 80:20 ratio. There will be one fractal cue that is not consistently paired with a taste. Participants will be asked to respond with a button press as soon as possible to indicate on which side of the fixation cross the stimuli appeared (providing a behavioral measure of reaction time to each cue).

    Baseline

  • Baseline Post-fMRI Ad Lib Food Intake

    Participants will be presented with a 20-item buffet spread that includes ultra-processed foods (high- and low-calorie), and minimally processed foods (high- and low-calorie). Participants first perform a taste test of 1g of each of the foods. They will then complete perceptual hedonic ratings of the pleasantness, sweetness, savoriness, and desire to consume on generalized labeled magnitude scales. After the taste test, participants will be told that they are free to eat as much as they like because the investigators have to discard the food after each participant. Participants will be alone during the 15-min tasting to minimize demand characteristics. Food will be pre- and post-weighed to determine ad lib intake. Total caloric intake will be calculated and translated to % of calorie needs.

    Baseline

Study Arms (1)

Adolescent youth age 13-15

age- and sex- adjusted body mass index (zBMI) scores between the 25th and 75th percentile

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • female and male adolescents 13-15 years of age
  • age- and sex- adjusted zBMI scores between the 25th and 75th percentile
  • participant and their guardian must be able to read and speak English to gather valid consent

You may not qualify if:

  • current eating disorders or other major psychiatric disorders (e.g., depression, bipolar, schizophrenia, substance use disorder)
  • fMRI contra-indicators (e.g., metal implants, braces, claustrophobia, pregnancy)
  • serious medical problems (e.g., Type 2 diabetes, cancer)
  • history of food allergies or restrictive dietary requirements (e.g., lactose intolerance, vegan)
  • use of psychoactive drugs more than once weekly
  • medications that impact appetite or reward functioning (e.g., metformin, anti-psychotic medication, insulin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Related Publications (8)

  • Hall KD, Ayuketah A, Brychta R, Cai H, Cassimatis T, Chen KY, Chung ST, Costa E, Courville A, Darcey V, Fletcher LA, Forde CG, Gharib AM, Guo J, Howard R, Joseph PV, McGehee S, Ouwerkerk R, Raisinger K, Rozga I, Stagliano M, Walter M, Walter PJ, Yang S, Zhou M. Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake. Cell Metab. 2019 Jul 2;30(1):67-77.e3. doi: 10.1016/j.cmet.2019.05.008. Epub 2019 May 16.

    PMID: 31105044BACKGROUND
  • Demos KE, Heatherton TF, Kelley WM. Individual differences in nucleus accumbens activity to food and sexual images predict weight gain and sexual behavior. J Neurosci. 2012 Apr 18;32(16):5549-52. doi: 10.1523/JNEUROSCI.5958-11.2012.

    PMID: 22514316BACKGROUND
  • Stice E, Burger KS, Yokum S. Reward Region Responsivity Predicts Future Weight Gain and Moderating Effects of the TaqIA Allele. J Neurosci. 2015 Jul 15;35(28):10316-24. doi: 10.1523/JNEUROSCI.3607-14.2015.

    PMID: 26180206BACKGROUND
  • Yokum S, Gearhardt AN, Harris JL, Brownell KD, Stice E. Individual differences in striatum activity to food commercials predict weight gain in adolescents. Obesity (Silver Spring). 2014 Dec;22(12):2544-51. doi: 10.1002/oby.20882. Epub 2014 Aug 25.

    PMID: 25155745BACKGROUND
  • Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, Mei Z, Curtin LR, Roche AF, Johnson CL. CDC growth charts: United States. Adv Data. 2000 Jun 8;(314):1-27.

    PMID: 11183293BACKGROUND
  • Joyner MA, Gearhardt AN, Flagel SB. A Translational Model to Assess Sign-Tracking and Goal-Tracking Behavior in Children. Neuropsychopharmacology. 2018 Jan;43(1):228-229. doi: 10.1038/npp.2017.196. No abstract available.

    PMID: 29192653BACKGROUND
  • Stice E, Yokum S, Rohde P, Cloud K, Desjardins CD. Comparing healthy adolescent females with and without parental history of eating pathology on neural responsivity to food and thin models and other potential risk factors. J Abnorm Psychol. 2021 Aug;130(6):608-619. doi: 10.1037/abn0000686.

    PMID: 34553956BACKGROUND
  • O'Doherty JP, Buchanan TW, Seymour B, Dolan RJ. Predictive neural coding of reward preference involves dissociable responses in human ventral midbrain and ventral striatum. Neuron. 2006 Jan 5;49(1):157-66. doi: 10.1016/j.neuron.2005.11.014.

    PMID: 16387647BACKGROUND

Study Officials

  • Eric Stice, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Stice, PhD

CONTACT

Teena Ambrose, BS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 12, 2023

Study Start

October 4, 2024

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations