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NCT Number: NCT06044285

Ultra Crave: An Investigation of Ultra-Processed Food

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.

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Key information

Age range

22 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Ashley Gearhardt, PhD

CONTACT

[email protected]

734-647-3920

About this study

The study will include a combination of in-person, at-home, and virtual activities over the course of ~14 days (contingent on scheduling, this duration may vary and particularly between in-person visits #1 and #2). Participants complete three in-lab visits. Visit 1 and 2 will each followed by a week of remote data tasks (e.g., EMA, continuous glucose monitoring, physical activity and sleep tracking (Fitbit), and two 24-hour dietary recall interviews).

During in-lab visit #1, participants will complete questionnaires, behavioral tasks, and interviews, and will have body composition measurements taken (height, weight, Inbody scan). Participants will complete the remote tasks for the following week while eating their typical diet (i.e., baseline period).

During in-lab visit #2, participants will complete questionnaires, interviews, and body composition measurements (height, weight, Inbody scan). Participants are randomly assigned to one of three conditions--control (i.e., high UP), self-guided low UP, or meals provided low UP--and will follow instructions about how to eat consistent with their condition during week 2 of remote data collection (i.e., dietary intervention period).

During in-lab visit #3, participants will complete questionnaires, behavioral tasks, body composition measurements (height, weight, InBody scan), and an fMRI scan.

Participants are contacted 1- and 3-months later to complete a short follow-up survey and provide information about their current diet.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low UP (meals provided)

Other

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)

Other

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

Other

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Reactivity to a stressor

    Time frame: Assessed post-dietary intervention during in-lab Visit 3 (1 day)

    Stress reactivity will be assessed using an in-lab stress task that has participants listen to an audio recording of a current stressor in their life. Participants' heart rate in response to the audio recording, relative to a baseline measurement, will be used as an indicator of stress reactivity; an increase in heart rate will be indicative of greater stress reactivity.

  2. Self-reported reactivity to a stressor

    Time frame: Assessed post-dietary intervention during in-lab Visit 3 (1 day)

    Stress reactivity will be assessed using an in-lab stress task that has participants listen to an audio recording of a current stressor in their life. Participants' subjective ratings of reactivity will be assessed at baseline (prior to listening to the audio recording) and immediately after listening to the audio recording using the negative affect subscale from the Positive and Negative Affect Schedule (PANAS); each item is rated on a 1 (very slightly or not at all) to 5 (extremely) scale, with higher numbers indicating greater experienced affect; an increase in score, relative to baseline, will indicate greater stress reactivity.

  3. Cue reactivity to a simulated fast food restaurant

    Time frame: Assessed post-dietary intervention during in-lab Visit 3 (1 day)

    Participants will spend 5 minutes in a simulated fast food restaurant. Participants' heart rate in response to the simulated fast food restaurant, relative to a baseline measurement, will be used as an indicator of cue reactivity; increases in will be indicative of greater cue reactivity.

  4. Self-reported cue reactivity to a simulated fast food restaurant

    Time frame: Assessed post-dietary intervention during in-lab Visit 3 (1 day)

    Participants will spend 5 minutes in a simulated fast food restaurant. Participants' subjective craving will be assessed at baseline (prior to entering the restaurant) and while in the restaurant on a scale from 0 (no craving at all) to 100 (I have never craved food more), with greater numbers indicating higher craving; an increase in score, relative to baseline, will indicate greater cue reactivity.

  5. Level of reinforcement value for ultra processed foods

    Time frame: Baseline assessed during in-lab Visit 1 (1 day); assessed again post-dietary intervention during in-lab Visit 3 (1 day)

    Participants will complete a computerized task that measures their willingness to work (i.e., reinforcement value) for a UP food gift card relative to a non-food gift card.

  6. Magnitude of neural reward-related response to tasting a milkshake

    Time frame: Assessed post-dietary intervention during in-lab Visit 3 (1 day)

    Participants will complete an fMRI paradigm where they see a UP food cue (i.e., picture of a chocolate milkshake) that predict receipt of a UP food (i.e., a chocolate milkshake). The paradigm also includes a control cue (i.e., picture of a water glass) that predicts receipt of a tasteless solution (which contains the ionic components of saliva; 25 mM KCl and 2.5 mM NaHCO3 in distilled water). Participants' activation in neural regions associated with reward (e.g., mOFC, striatum) to the milkshake cue (relative to the water cue) will be used as a measure of increased reward-related response to UP food cues.

  7. Blood Glucose Level

    Time frame: Assessed during dietary intervention period for 1 week

    Assessed using a continuous blood glucose monitor.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Gearhardt, PhD

CONTACT

[email protected]

734-647-3920

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Brown University
  • National Institute on Drug Abuse (NIDA)
  • Oregon Research Institute
  • Pennington Biomedical Research Center
  • University of Tasmania

Registry information

Official study title

Ultra Crave: A Biopsychobehavioral Investigation of Withdrawal From Ultra-Processed Food in Humans

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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