Investigating the effects of reducing ultra-processed food intake on food addiction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Study coordinator: Ashley Gearhardt, PhD
• Email: agearhar@umich.edu
• Phone: 734-647-3920

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.