Ultra Crave: An Investigation of Ultra-Processed Food

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

Qualifiers

22 to 60 years of age

English-speaking

Must own an Android or iPhone Smartphone

Live within a 1-hour radius of the laboratory

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

210 Participants
are divided into 3 treatment groups

Sponsors and collaborators

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