Ultra Crave: An Investigation of Ultra-Processed Food
ConditionFood Addiction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-60
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
22 to 60 years of age
English-speaking
Must own an Android or iPhone Smartphone
Able and willing to commute to the laboratory
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Low UP (meals provided)
Other interventionThis 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)
Other interventionVisit 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
Other interventionVisit 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.
Treatment groups
210 Participants
are divided into 3 treatment groupsGroup A: Self-Guided Low UP Food DietExperimental treatment 1 intervention
Group B: Meals Provided Low UP Food DietExperimental treatment 1 intervention
Group C: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed during dietary intervention period for 1 week2
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.
Time frame
Assessed during dietary intervention period for 1 week3
Low UP food intake
Intake of low UP foods will be assessed using two 24 hour dietary recall interviews.
Time frame
Assessed during dietary intervention period for 1 week4
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.
Time frame
Assessed during dietary intervention period for 1 weekSecondary outcomes
1
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.
Time frame
Assessed post-dietary intervention during in-lab Visit 3 (1 day)2
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.
Time frame
Assessed post-dietary intervention during in-lab Visit 3 (1 day)3
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.
Time frame
Assessed post-dietary intervention during in-lab Visit 3 (1 day)4
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.
Time frame
Assessed post-dietary intervention during in-lab Visit 3 (1 day)Sponsors and contacts
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University of Michigan
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Oregon Research Institute
Collaborator
University of Tasmania
Collaborator
Brown University
Collaborator
Pennington Biomedical Research Center
Collaborator
Source ClinicalTrials.gov