Actively Recruiting
Ultra Crave: A Biopsychobehavioral Investigation of Withdrawal From Ultra-Processed Food in Humans
Led by University of Michigan · Updated on 2026-05-19
210
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying food addiction by examining whether reducing intake of ultra-processed (UP) foods causes withdrawal symptoms, increases cravings, and affects adherence to a low-UP diet. The study tests if physical, cognitive, and emotional withdrawal symptoms occur and whether cravings for UP foods rise when intake is lowered. It also explores if these factors lead to difficulty sticking to a diet low in UP foods. Participants take part in three in-lab visits combined with remote activities over about two weeks. The first visit and following week track baseline behavior while on their usual diet. The second visit introduces a dietary intervention where participants are randomly assigned to continue their regular diet, follow a self-guided low-UP diet, or receive meals provided by the study team with low UP foods. The third visit evaluates post-intervention outcomes, including brain scans and behavioral tests. Follow-up surveys occur 1 and 3 months later. During the study, participants complete questionnaires, interviews, behavioral tasks, and body composition measurements. Remote monitoring includes daily food intake reports, phone interviews about diet, continuous glucose monitoring, and physical activity and sleep tracking using Fitbit devices. Researchers measure withdrawal symptoms, cravings, food intake, blood glucose, stress responses, and brain activity related to food rewards to understand the effects of reducing UP food consumption.
CONDITIONS
Brief Title
Ultra Crave: An Investigation of Ultra-Processed Food
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 22 to 60 years
- English-speaking
- Own an Android or iPhone smartphone
- Live within a 1-hour radius of the laboratory
- Endorse more than 4 symptoms on the YFAS 2.0 questionnaire at screening and consent
- Willing and able to follow specific dietary instructions from 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 food intake
- Like the taste of chocolate milkshake (for fMRI scan eligibility)
You will not qualify if you...
- Body mass index (BMI) below 18.5 or above 40
- Current diagnosis of disorders affecting study results or safe participation, such as uncontrolled hypothyroidism or diabetes
- History of food allergies
- Unable to respond to brief questionnaires within 90 minutes during the day
- Work night shifts or irregular work shifts
- Restrictive dietary requirements like veganism or high picky eating
- Use of medications that affect study results or safety, such as insulin or antipsychotics
- Diagnosis of severe mental illness (e.g., schizophrenia, bipolar disorder)
- Diagnosis of restrictive eating disorders within the last 5 years
- Current disorders impacting reward or metabolic function
- Weight fluctuation over 20 pounds in the last 3 months
- Prior weight loss surgery
- Currently pregnant, breastfeeding, trying to get pregnant, or within 6 months postpartum
- High-risk or high 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, tobacco, or nicotine during the main study period (~22 days)
- fMRI contraindications such as claustrophobia or metal implants
- Inability to complete a random report within 90 minutes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Approximately 1 week
Participants complete in-lab questionnaires, behavioral tasks, interviews, and body composition measurements, followed by a week of remote data collection while eating their typical diet.
1 in-person baseline visit and 7 days of remote data tasks
Duration - Approximately 1 week
Participants complete in-lab questionnaires, interviews, and body composition measurements, then follow dietary instructions according to their assigned condition during a week of remote data collection.
1 in-person visit and 7 days of remote data tasks
Duration - 1 day
Participants complete in-lab questionnaires, behavioral tasks, body composition measurements, and an fMRI scan to assess outcomes post dietary intervention.
1 in-person visit
Duration - Up to 3 months
Participants complete remote surveys at 1 month and 3 months after the intervention to provide information about their current diet.
2 remote follow-up surveys
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
A
Ashley Gearhardt, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here