Investigating the effects of reducing ultra-processed food intake on food addiction
Ultra Crave: A Biopsychobehavioral Investigation of Withdrawal From Ultra-Processed Food in Humans
This study tests if reducing ultra-processed foods can help people with food addiction feel better and stick to a healthier diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 22 Years to 60 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06044285 on ClinicalTrials.gov |
What this trial studies
This study examines how cutting back on ultra-processed (UP) foods affects withdrawal symptoms and adherence to a low-UP diet. Participants will undergo a series of in-person and remote assessments over approximately 14 days, including questionnaires, behavioral tasks, and dietary tracking. They will be randomly assigned to either a control group or one of two low-UP diet conditions, with follow-up assessments to evaluate their dietary habits and symptoms. The study aims to understand the relationship between UP food intake and food addiction symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 to 60 who exhibit symptoms of food addiction and are willing to follow specific dietary instructions.
Not a fit: Patients with a self-reported BMI below 18.5 or above 40, or those with certain medical conditions that may affect study outcomes, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective dietary interventions for individuals struggling with food addiction.
How similar studies have performed: While the investigation of food addiction and dietary interventions is ongoing, this specific approach to studying ultra-processed food withdrawal is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Ashley Gearhardt, PhD
- Email: agearhar@umich.edu
- Phone: 734-647-3920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.