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NCT06044285 · ClinicalTrials.gov registry record · NA
Ultra Crave: An Investigation of Ultra-Processed Food
A NA study of Food Addiction, sponsored by University of Michigan.
- Recruiting
- Registry status
- NA
- Development phase
- 210
- Enrollment target
- 1
- Study location
NCT06044285 is a NA study of Food Addiction that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 210 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06044285, a NA study of Food Addiction, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Low UP (meals provided)
- OTHER Low UP (self-guided)
- OTHER Active Control
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2023-08-05 |
| Est. Completion | 2028-08-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06044285
The ClinicalTrials.gov registry entry for NCT06044285 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Food Addiction appearing as the primary indexed condition, and to 3 interventions - of which Low UP (meals provided) is the first listed.
NCT06044285 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT06044285 about?
NCT06044285 is a clinical study titled "Ultra Crave: An Investigation of Ultra-Processed Food". 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 follow...
What is the current status of trial NCT06044285?
This trial is currently recruiting. It is a NA study. The enrollment target is 210 participants. The study started on 2023-08-05. Estimated completion is 2028-08-05.
What conditions does trial NCT06044285 study?
This clinical trial studies the following conditions: Food Addiction.
What interventions are being tested in trial NCT06044285?
The interventions under investigation include: Low UP (meals provided) (OTHER), Low UP (self-guided) (OTHER), Active Control (OTHER).
Who is sponsoring clinical trial NCT06044285?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06044285 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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