RECRUITING

Ultra Crave: An Investigation of Ultra-Processed Food

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Conditions

Food AddictionWithdrawalHighly Processed Foods

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ultra Crave: A Biopsychobehavioral Investigation of Withdrawal From Ultra-Processed Food in Humans

Quick Facts

Study Start:2023-08-05
Study Completion:2028-08-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06044285

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 22 to 60 years of age
  2. * English-speaking
  3. * Must own an Android or iPhone Smartphone
  4. * Live within a 1-hour radius of the laboratory
  5. * 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)
  6. * Willing and able to follow specific dietary instructions provided by the study team
  7. * Willing and able to attend 3 in-person lab visits
  8. * Willing to complete 4 phone interviews about foods eaten in the past 24 hours
  9. * Willing to report daily intake of food
  10. * Like the taste of chocolate milkshake (for fMRI scan eligibility only).
  1. * participants with a self-reported BMI \< 18.5 and \> 40
  2. * Current diagnosis of disorder that may impact study results or the ability to safely complete study tasks (hypothyroidism (uncontrolled by medication), diabetes, etc.)
  3. * History of food allergies
  4. * Unable to respond to brief questionnaires within 90-minutes during the day
  5. * Work night shifts or irregular shifts
  6. * Restrictive dietary requirements (e.g., vegan) or high levels of picky eating
  7. * Medications (e.g., insulin, antipsychotic medications) that may impact study results or safe completion of study tasks
  8. * Diagnosis of severe mental illness (e.g., schizophrenia, bipolar disorder)
  9. * Diagnosis of a restrictive eating disorder (e.g., Anorexia Nervosa, Bulimia Nervosa, purging disorder) within the last 5 years
  10. * Current diagnoses of disorders that can impact reward/metabolic functioning
  11. * 20+ pound weight fluctuation in the last 3-months
  12. * Prior weight loss surgery (e.g., bariatric surgery)
  13. * Currently pregnant, breastfeeding, trying to get pregnant, or within 6-months of having given birth
  14. * High levels or high-risk intake of alcohol or caffeine
  15. * Use of tobacco or nicotine in the past month
  16. * Use of THC cannabis within the past week
  17. * Unwillingness to abstain from THC cannabis, tobacco or nicotine during the main portion of the study (\~22 days)
  18. * fMRI contraindications (e.g., claustrophobia, metal implants).
  19. * inability to complete a random report within 90 minutes

Contacts and Locations

Study Contact

Ashley Gearhardt, PhD
CONTACT
734-647-3920
agearhar@umich.edu

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-05
Study Completion Date2028-08-05

Study Record Updates

Study Start Date2023-08-05
Study Completion Date2028-08-05

Terms related to this study

Keywords Provided by Researchers

  • Withdrawal
  • Food Addiction
  • Highly Processed Foods

Additional Relevant MeSH Terms

  • Food Addiction