Ultra Crave: An Investigation of Ultra-Processed Food

Food Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044285
• Other study ID #: HUM00226716
• Secondary ID: 1R01DA055027-01A
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2023
• Est. completion date: August 5, 2028

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Ashley Gearhardt, PhD
• Phone: 734-647-3920
• Email: agearhar[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will include a combination of in-person, at-home, and virtual activities over the course of ~14 days (contingent on scheduling, this duration may vary and particularly between in-person visits #1 and #2). Participants complete three in-lab visits. Visit 1 and 2 will each followed by a week of remote data tasks (e.g., EMA, continuous glucose monitoring, physical activity and sleep tracking (Fitbit), and two 24-hour dietary recall interviews).

During in-lab visit #1, participants will complete questionnaires, behavioral tasks, and interviews, and will have body composition measurements taken (height, weight, Inbody scan). Participants will complete the remote tasks for the following week while eating their typical diet (i.e., baseline period).

During in-lab visit #2, participants will complete questionnaires, interviews, and body composition measurements (height, weight, Inbody scan). Participants are randomly assigned to one of three conditions--control (i.e., high UP), self-guided low UP, or meals provided low UP--and will follow instructions about how to eat consistent with their condition during week 2 of remote data collection (i.e., dietary intervention period).

During in-lab visit #3, participants will complete questionnaires, behavioral tasks, body composition measurements (height, weight, InBody scan), and an fMRI scan.

Participants are contacted 1- and 3-months later to complete a short follow-up survey and provide information about their current diet.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: August 5, 2028
• Est. primary completion date: August 5, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 60 Years

Eligibility

Inclusion Criteria:

• 22 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).

Exclusion Criteria:

• 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

• 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).

• inability to complete a random report within 90 minutes

Related Conditions & MeSH terms

• Behavior, Addictive
• Food Addiction

Intervention

Other:
• Low UP (meals provided)
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.
• Low UP (self-guided)
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.
• Active Control
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (6)

Lead Sponsor	Collaborator
University of Michigan	Brown University, National Institute on Drug Abuse (NIDA), Oregon Research Institute, Pennington Biomedical Research Center, University of Tasmania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Reactivity to a stressor	Stress reactivity will be assessed using an in-lab stress task that has participants listen to an audio recording of a current stressor in their life. Participants' heart rate in response to the audio recording, relative to a baseline measurement, will be used as an indicator of stress reactivity; an increase in heart rate will be indicative of greater stress reactivity.	Assessed post-dietary intervention during in-lab Visit 3 (1 day)
Secondary	Self-reported reactivity to a stressor	Stress reactivity will be assessed using an in-lab stress task that has participants listen to an audio recording of a current stressor in their life. Participants' subjective ratings of reactivity will be assessed at baseline (prior to listening to the audio recording) and immediately after listening to the audio recording using the negative affect subscale from the Positive and Negative Affect Schedule (PANAS); each item is rated on a 1 (very slightly or not at all) to 5 (extremely) scale, with higher numbers indicating greater experienced affect; an increase in score, relative to baseline, will indicate greater stress reactivity.	Assessed post-dietary intervention during in-lab Visit 3 (1 day)
Secondary	Cue reactivity to a simulated fast food restaurant	Participants will spend 5 minutes in a simulated fast food restaurant. Participants' heart rate in response to the simulated fast food restaurant, relative to a baseline measurement, will be used as an indicator of cue reactivity; increases in will be indicative of greater cue reactivity.	Assessed post-dietary intervention during in-lab Visit 3 (1 day)
Secondary	Self-reported cue reactivity to a simulated fast food restaurant	Participants will spend 5 minutes in a simulated fast food restaurant. Participants' subjective craving will be assessed at baseline (prior to entering the restaurant) and while in the restaurant on a scale from 0 (no craving at all) to 100 (I have never craved food more), with greater numbers indicating higher craving; an increase in score, relative to baseline, will indicate greater cue reactivity.	Assessed post-dietary intervention during in-lab Visit 3 (1 day)
Secondary	Level of reinforcement value for ultra processed foods	Participants will complete a computerized task that measures their willingness to work (i.e., reinforcement value) for a UP food gift card relative to a non-food gift card.	Baseline assessed during in-lab Visit 1 (1 day); assessed again post-dietary intervention during in-lab Visit 3 (1 day)
Secondary	Magnitude of neural reward-related response to tasting a milkshake	Participants will complete an fMRI paradigm where they see a UP food cue (i.e., picture of a chocolate milkshake) that predict receipt of a UP food (i.e., a chocolate milkshake). The paradigm also includes a control cue (i.e., picture of a water glass) that predicts receipt of a tasteless solution (which contains the ionic components of saliva; 25 mM KCl and 2.5 mM NaHCO3 in distilled water). Participants' activation in neural regions associated with reward (e.g., mOFC, striatum) to the milkshake cue (relative to the water cue) will be used as a measure of increased reward-related response to UP food cues.	Assessed post-dietary intervention during in-lab Visit 3 (1 day)
Secondary	Blood Glucose Level	Assessed using a continuous blood glucose monitor.	Assessed during dietary intervention period for 1 week