Actively Recruiting

Phase Not Applicable
Age: 22Years - 60Years
All Genders
NCT06044285

Ultra Crave: An Investigation of Ultra-Processed Food

Led by University of Michigan · Updated on 2025-05-14

210

Participants Needed

1

Research Sites

261 weeks

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

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.

CONDITIONS

Official Title

Ultra Crave: An Investigation of Ultra-Processed Food

Who Can Participate

Age: 22Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 22 and 60 years
  • Speak English
  • 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 for food addiction at screening and consent
  • Willing and able to follow specific dietary instructions
  • Willing and able to attend 3 in-person lab visits
  • Willing to complete 4 phone interviews about foods eaten
  • Willing to report daily food intake
  • Like the taste of chocolate milkshake (for fMRI eligibility only)
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) less than 18.5 or greater than 40
  • Current diagnosis of disorders impacting study safety or results (e.g., uncontrolled hypothyroidism, diabetes)
  • History of food allergies
  • Unable to respond to brief questionnaires within 90 minutes during the day
  • Work night shifts or irregular shifts
  • Restrictive diets (e.g., vegan) or high picky eating
  • Use medications affecting study results or safety (e.g., insulin, antipsychotics)
  • Diagnosis of severe mental illness (e.g., schizophrenia, bipolar disorder)
  • Diagnosis of restrictive eating disorder within past 5 years
  • Current diagnoses affecting reward or metabolic function
  • Weight change over 20 pounds in last 3 months
  • Prior weight loss surgery
  • Currently pregnant, breastfeeding, trying to get pregnant, or within 6 months postpartum
  • High or risky intake of alcohol or caffeine
  • Use of tobacco or nicotine in past month
  • Use of THC cannabis within past week
  • Unwillingness to abstain from THC, tobacco, or nicotine during study (~22 days)
  • Contraindications for fMRI (e.g., claustrophobia, metal implants)
  • Inability to complete a random questionnaire within 90 minutes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

A

Ashley Gearhardt, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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