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Behavioural Intervention

Dietary Changes for Food Addiction

N/A
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
25 to 60 years of age
Be between 18 and 65 years old
Must not have
Type 1 or Type 2 diabetes, pre-diabetes, hypoclycemia
Medications that impact appetite or reward functioning (e.g., anti-psychotic medication, insulin)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline assessed during in-lab visit 1 (1 day); assessed again post-dietary intervention during in-lab visit 3 (1 day)
Awards & highlights

Summary

This trial investigates whether reducing ultra-processed food intake causes withdrawal, & increases motivation for UP food, which affects ability to adhere to a low-UP diet.

Who is the study for?
This trial is for English-speaking adults aged 25-60 who believe they have a food addiction, consume multiple ultra-processed foods daily, and live close to the lab. They must be willing to follow dietary instructions and like chocolate milkshakes (for fMRI). Exclusions include diabetes, severe mental illness history, recent pregnancy or breastfeeding, high caffeine/alcohol intake, certain medical conditions and treatments affecting metabolism or reward functioning.Check my eligibility
What is being tested?
The study tests if reducing ultra-processed food intake causes withdrawal symptoms that make it hard to stick with the diet. Participants will switch between high and low processed food diets while researchers monitor their cravings, stress responses, brain activity related to rewards, blood glucose levels, and overall ability to maintain the diet.See study design
What are the potential side effects?
Potential side effects may include physical discomforts such as headaches or fatigue due to withdrawal from ultra-processed foods; cognitive challenges like difficulty concentrating; emotional changes including irritability; increased craving for unhealthy foods; and possible stress response during adaptation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes or pre-diabetes.
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I am not taking medications that affect my appetite or feelings of pleasure.
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I am color blind to red and green.
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I have had weight loss surgery in the past.
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My weight has changed by more than 20 pounds in the last 3 months.
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I cannot complete a survey within 90 minutes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline assessed during in-lab visit 1 (1 day); assessed again post-dietary intervention during in-lab visit 3 (1 day)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline assessed during in-lab visit 1 (1 day); assessed again post-dietary intervention during in-lab visit 3 (1 day) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Craving of ultra-processed (UP) foods
Low UP food intake
Self-Reported Low UP food intake
+1 more
Secondary outcome measures
Blood Glucose Level
Cue reactivity to a simulated fast food restaurant
Level of reinforcement value for ultra processed foods
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Self-Guided Low UP Food DietExperimental Treatment1 Intervention
Participants asked to eat a low UP food diet according to study provided nutritional guidance.
Group II: Meals Provided Low UP Food DietExperimental Treatment1 Intervention
.Participants asked to eat a low UP food diet provided by the study team.
Group III: ControlActive Control1 Intervention
Participants asked to eat as they usually do.

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterOTHER
306 Previous Clinical Trials
181,824 Total Patients Enrolled
University of TasmaniaOTHER
12 Previous Clinical Trials
109,269 Total Patients Enrolled
Brown UniversityOTHER
459 Previous Clinical Trials
559,147 Total Patients Enrolled
~140 spots leftby Aug 2028