Recruiting

Ultra-Processed FoodUltra Crave: An Investigation of Ultra-Processed Food

Sponsor:

University of Michigan

Code:

NCT06044285

Conditions

Food Addiction

Eligibility Criteria

Sex: All

Age: 22 - 60

Healthy Volunteers: Not accepted

Interventions

Low UP (meals provided)

Low UP (self-guided)

Active Control

Study Details

Brief summary:

This study experimentally investigates whether a reduction in ultra-processed (UP) food intake (1) causes aversive withdrawal symptoms in humans, (2) increases the motivational salience of UP food cues and, if so, (3) whether these factors undermine the ability to adhere to a low-UP diet. The following aims and hypotheses are tested:

Aim 1: To investigate whether aversive physical, cognitive, and affective withdrawal symptoms emerge in response to reduced UP food intake compared to a high-UP diet, and whether this predicts failure to adhere to a low-UP diet.

H1a: Reducing UP food intake will result in aversive physical, cognitive, and affective withdrawal symptoms, as indicated by 1) ecological momentary assessment (EMA) reports of aversive withdrawal symptoms, and 2) heart rate reactivity and subjective distress to an in-lab stressor.

H1b: Aversive symptoms of UP food withdrawal will predict greater UP food intake and higher blood glucose levels when trying to adhere to a low UP diet.

Aim 2: To investigate whether increased motivational salience of UP food cues emerges in response to reduced UP food intake, and whether this predicts failure to maintain a low-UP diet.

H2a: Reducing UP food intake will result in increased motivational salience of UP food cues, as indicated by 1) EMA reports of UP food craving, 2) heart rate reactivity and subjective craving in a simulated fast-food restaurant, 3) heightened reinforcement value for UP food relative to other reinforcers, and 4) greater reward-related neural response to UP food cues.

H2b: Increased motivational salience of UP food cues will predict greater UP food intake and higher blood glucose levels when trying to adhere to a low UP diet.

Conditions

Food Addiction

Study ID

NCT06044285

Start date

Aug 5, 2023

Status verified date

May, 2026

Completion date

Aug 5, 2028

Anticipated

Primary completion date

Aug 5, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 22 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

22 to 60 years of age
English-speaking
Must own an Android or iPhone Smartphone
Live within a 1-hour radius of the laboratory
endorsement of > 4 symptoms on the YFAS 2.0 completed during eligibility screener; at the time of consent, symptom count must remain above threshold for food addiction (this discrepany is based on a previously found tendency during pilot testing to overestimate food addiction symptoms at the time of screening)
Willing and able to follow specific dietary instructions provided by the study team
Willing and able to attend 3 in-person lab visits
Willing to complete 4 phone interviews about foods eaten in the past 24 hours
Willing to report daily intake of food
Like the taste of chocolate milkshake (for fMRI scan eligibility only).

Exclusion Criteria:

participants with a self-reported BMI < 18.5 and > 40
Current diagnosis of disorder that may impact study results or the ability to safely complete study tasks (hypothyroidism (uncontrolled by medication), diabetes, etc.)
History of food allergies
Unable to respond to brief questionnaires within 90-minutes during the day
Work night shifts or irregular shifts
Restrictive dietary requirements (e.g., vegan) or high levels of picky eating
Medications (e.g., insulin, antipsychotic medications) that may impact study results or safe completion of study tasks
Diagnosis of severe mental illness (e.g., schizophrenia, bipolar disorder)
Diagnosis of a restrictive eating disorder (e.g., Anorexia Nervosa, Bulimia Nervosa, purging disorder) within the last 5 years
Current diagnoses of disorders that can impact reward/metabolic functioning
20+ pound weight fluctuation in the last 3-months
Prior weight loss surgery (e.g., bariatric surgery)
Currently pregnant, breastfeeding, trying to get pregnant, or within 6-months of having given birth
High levels or high-risk intake of alcohol or caffeine
Use of tobacco or nicotine in the past month
Use of THC cannabis within the past week
Unwillingness to abstain from THC cannabis, tobacco or nicotine during the main portion of the study (\~22 days)
fMRI contraindications (e.g., claustrophobia, metal implants).
inability to complete a random report within 90 minutes

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Self-Guided Low UP Food Diet

Participants asked to eat a low UP food diet according to study provided nutritional guidance.

experimental: Meals Provided Low UP Food Diet

.Participants asked to eat a low UP food diet provided by the study team.

active comparator: Control

Participants asked to eat as they usually do.

Interventions

Low UP (meals provided)

This study incorporates within- and between-subject comparisons. All participants complete a series of three in-lab visits with remote data collection:

Visit 1 and the following week comprise the baseline assessment period.

Visit 2 and the following week comprise the dietary intervention period. Food is provided by the study team for 7 days in accordance with a low UP diet.

Visit 3 assesses post-dietary intervention outcomes. All participants will complete remote assessments at 1 month and 3 month follow-up.

Low UP (self-guided)

Visit 1 and the following week comprise the baseline assessment period.

Visit 2 and the following week comprise the dietary intervention period. Participants are asked to eat a low UP diet according to study provided nutritional guidance.

Visit 3 assesses post-dietary intervention outcomes. All participants will complete remote assessments at 1 month and 3 month follow-up.

Active Control

Visit 1 and the following week comprise the baseline assessment period.

Visit 2 and the following week comprise the dietary intervention period. Participants are asked to eat as they normally do.

Visit 3 assesses post-dietary intervention outcomes. All participants will complete remote assessments at 1 month and 3 month follow-up.

Primary outcome measure

Withdrawal Symptoms [ Time Frame: Assessed during dietary intervention period for 1 week ]
Craving of ultra-processed (UP) foods [ Time Frame: Assessed during dietary intervention period for 1 week ]
Low UP food intake [ Time Frame: Assessed during dietary intervention period for 1 week ]
Self-Reported Low UP food intake [ Time Frame: Assessed during dietary intervention period for 1 week ]

Central Contacts and Locations

Central contacts

Ashley Gearhardt, PhD

734-647-3920 agearhar@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Ashley Gearhardt, PhD

734-647-3920 agearhar@umich.edu

More Information

Sponsor

University of Michigan

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

Withdrawal
Food Addiction
Highly Processed Foods

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-05-19.