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RECRUITING
NCT06044285
NA

Ultra Crave: An Investigation of Ultra-Processed Food

Sponsor: University of Michigan

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

22 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2023-08-05

Completion Date

2028-08-05

Last Updated

2025-05-14

Healthy Volunteers

No

Conditions

Interventions

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.

OTHER

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.

OTHER

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 (1)

University of Michigan

Ann Arbor, Michigan, United States