NCT06044285 Ultra Crave: An Investigation of Ultra-Processed Food
| NCT ID | NCT06044285 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Food Addiction |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2023-08-05 |
| Primary Completion | 2028-08-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2023-08-05 with a primary completion date of 2028-08-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 22 to 60 years of age * English-speaking * Must own an Android or iPhone Smartphone * Able and willing to commute to 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 * 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, BMI \>40, etc; Note: this is an fMRI-specific exclusion criterion. participants may be allowed to participate in all other study measures that do not involve fMRI). * inability to complete a random report within 90 minutes
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06044285 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 60 Years, studying Food Addiction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06044285 currently recruiting?
Yes, NCT06044285 is actively recruiting participants. Contact the research team at agearhar@umich.edu for enrollment information.
Where is the NCT06044285 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06044285 clinical trial?
NCT06044285 is sponsored by University of Michigan. The trial plans to enroll 210 participants.
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