Ultra Crave: An Investigation of Ultra-Processed Food

Conditions

• Food Addiction

Eligibility Criteria

Sex

ALL

Age

22 Years - 60 Years

Healthy Volunteers

Not accepted

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.
• 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.
• 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.

Study Details

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.

Key Dates

Start date

Aug 5, 2023

Status verified

May 2026

Primary completion

Aug 5, 2028

Completion

Aug 5, 2028

Study Design

Enrollment

210 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Self-Guided Low UP Food Diet
  Participants asked to eat a low UP food diet according to study provided nutritional guidance.
• Experimental: Meals Provided Low UP Food Diet
  .Participants asked to eat a low UP food diet provided by the study team.
• Active Comparator: Control
  Participants asked to eat as they usually do.

Primary Outcome Measure

Withdrawal Symptoms [ Time Frame: Assessed during dietary intervention period for 1 week ]

Central Contacts

• Ashley Gearhardt, PhD
  734-647-3920
  [email protected]

Locations (1)

Find similar trials in Ann Arbor, MI

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