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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

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

Study 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

Select...

I am between 25 and 60 years old.

Timeline

Screening ~ 3 weeks3 visits

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)

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterOTHER

305 Previous Clinical Trials

181,826 Total Patients Enrolled

University of TasmaniaOTHER

11 Previous Clinical Trials

9,269 Total Patients Enrolled

Brown UniversityOTHER

456 Previous Clinical Trials

558,144 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research require participants to be less than octogenarian?

"This medical trial is recruiting patients aged between 25 and 60 years old."

Answered by AI

What criteria qualify someone as a viable participant in this experiment?

"To become a part of this clinical trial, participants must present with compulsive eating and be between 25 to 60 years old. Currently, about 400 individuals are being admitted into the study."

Answered by AI

Does this research endeavor need more participants?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is presently in need of participants, which were initially posted on August 5th 2023 and edited as recently as September 12th 2023. The research endeavour seeks 400 patients from a single location to participate."

Answered by AI

How many participants is this clinical trial allowing to join?

"Affirmative. According to the information available on clinicaltrials.gov, this medical research was initially posted on August 5th 2023 and is currently searching for 400 participants from 1 healthcare setting. The study has been recently updated as of 12 September 2023."

Answered by AI

What tangible improvements are investigators hoping to observe as a result of this research?

"This single week trial seeks to evaluate the impact of dietary interventions on individuals' cravings for ultra-processed (UP) foods. Additionally, participants will have their self-reported reactivity to a stressor assessed using an in-lab audio recording task and also experience a simulated fast food restaurant where both heart rate and subjective craving ratings will be taken as indicators of cue reactivity."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ultra Crave: An Investigation of Ultra-Processed Food

Ashley Gearhardt 2023. "Ultra Crave: An Investigation of Ultra-Processed Food". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06044285.

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