NCT06044285 · University of Michigan
Ultra Crave: An Investigation of Ultra-Processed Food
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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.
OTHER
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.
OTHER
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 measures
Withdrawal Symptoms
Time frame: Assessed during dietary intervention period for 1 week
Withdrawal symptoms (e.g., anger, anxiety) will be assessed using ecological momentary assessment (EMA) on a scale from 1 (not at all) to 7 (extremely); higher scores indicate greater withdrawal symptoms.
Craving of ultra-processed (UP) foods
Time frame: Assessed during dietary intervention period for 1 week
Craving of UP foods will be assessed using EMA on a scale from 1 (not at all) to 7 (extremely); higher scores indicate greater craving of UP foods.
Low UP food intake
Time frame: Assessed during dietary intervention period for 1 week
Intake of low UP foods will be assessed using two 24 hour dietary recall interviews.
Self-Reported Low UP food intake
Time frame: Assessed during dietary intervention period for 1 week
Intake of low UP foods will be assessed using EMA reports of food intake. Responses will be coded into high and low UP food intake based on the NOVA classification.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Ann Arbor, Michigan
Collaborators
National Institute on Drug Abuse (NIDA), Oregon Research Institute, University of Tasmania, Brown University, Pennington Biomedical Research Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations