Ultra Crave: An Investigation of Ultra-Processed Food

NCT06044285 | Recruiting

• 2 other identifiers: HUM002267161R01DA055027-01A1
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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 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

Food Addiction

Keywords

Withdrawal; Food Addiction; Highly Processed Foods

Outcome Measures

Primary Outcomes (4)

• Withdrawal Symptoms

  Withdrawal symptoms (e.g., anger, anxiety) will be assessed using ecological momentary assessment (EMA) on a scale from 1 (not at all) to 7 (extremely); higher scores indicate greater withdrawal symptoms.

  Assessed during dietary intervention period for 1 week

• Craving of ultra-processed (UP) foods

  Craving of UP foods will be assessed using EMA on a scale from 1 (not at all) to 7 (extremely); higher scores indicate greater craving of UP foods.

  Assessed during dietary intervention period for 1 week

• Low UP food intake

  Intake of low UP foods will be assessed using two 24 hour dietary recall interviews.

  Assessed during dietary intervention period for 1 week

• Self-Reported Low UP food intake

  Intake of low UP foods will be assessed using EMA reports of food intake. Responses will be coded into high and low UP food intake based on the NOVA classification.

  Assessed during dietary intervention period for 1 week

Secondary Outcomes (7)

• Reactivity to a stressor

  Assessed post-dietary intervention during in-lab Visit 3 (1 day)

• Self-reported reactivity to a stressor

  Assessed post-dietary intervention during in-lab Visit 3 (1 day)

• Cue reactivity to a simulated fast food restaurant

  Assessed post-dietary intervention during in-lab Visit 3 (1 day)

• Self-reported cue reactivity to a simulated fast food restaurant

  Assessed post-dietary intervention during in-lab Visit 3 (1 day)

• Level of reinforcement value for ultra processed foods

  Baseline assessed during in-lab Visit 1 (1 day); assessed again post-dietary intervention during in-lab Visit 3 (1 day)

Study Arms (3)

Self-Guided Low UP Food Diet

EXPERIMENTAL

Participants asked to eat a low UP food diet according to study provided nutritional guidance.

Other: Low UP (self-guided)

Meals Provided Low UP Food Diet

EXPERIMENTAL

.Participants asked to eat a low UP food diet provided by the study team.

Other: Low UP (meals provided)

Control

ACTIVE COMPARATOR

Participants asked to eat as they usually do.

Other: Active Control

Interventions

Low UP (meals provided) OTHER

This study incorporates within- and between-subject comparisons. All participants complete a series of three in-lab visits with remote data collection: Visit 1 and the following week comprise the baseline assessment period. Visit 2 and the following week comprise the dietary intervention period. Food is provided by the study team for 7 days in accordance with a low UP diet. Visit 3 assesses post-dietary intervention outcomes. All participants will complete remote assessments at 1 month and 3 month follow-up.

Meals Provided Low UP Food Diet

Low UP (self-guided) OTHER

Visit 1 and the following week comprise the baseline assessment period. Visit 2 and the following week comprise the dietary intervention period. Participants are asked to eat a low UP diet according to study provided nutritional guidance. Visit 3 assesses post-dietary intervention outcomes. All participants will complete remote assessments at 1 month and 3 month follow-up.

Self-Guided Low UP Food Diet

Active Control OTHER

Visit 1 and the following week comprise the baseline assessment period. Visit 2 and the following week comprise the dietary intervention period. Participants are asked to eat as they normally do. Visit 3 assesses post-dietary intervention outcomes. All participants will complete remote assessments at 1 month and 3 month follow-up.

Control

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• + 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Oregon Research Institute: collaborator
• University of Tasmania: collaborator
• Brown University: collaborator
• Pennington Biomedical Research Center: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Food Addiction

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Feeding and Eating Disorders; Mental Disorders

Central Study Contacts

Ashley Gearhardt, PhD

CONTACT

734-647-3920; agearhar@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to the participants' condition. The study coordinator will oversee the randomization protocol.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology, College of Literature, Science, and the Arts

Model Details: Multi-method, within subjects, perspectives, experimental design

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: September 21, 2023
• Study Start: August 5, 2023
• Primary Completion (Estimated): August 5, 2028
• Study Completion (Estimated): August 5, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 1 year and ending 7 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal will be able to access data to achieve aims outlined in the approved proposal. Proposals should be directed to agearhar@umich.edu to gain access. Data requestors will need to sign a data access agreement.

Locations

US (1)