Status:
RECRUITING
Ultra Crave: An Investigation of Ultra-Processed Food
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Oregon Research Institute
Conditions:
Food Addiction
Eligibility:
All Genders
22-60 years
Phase:
NA
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 cue...
Detailed Description
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 vis...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 5 2028
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06044285
Start Date
August 5 2023
End Date
August 5 2028
Last Update
May 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan
Ann Arbor, Michigan, United States, 48109