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Behavioural Intervention
Ultra-Processed Foods' Impact on Obesity
Verified Trial
N/A
Recruiting
Research Sponsored by Drexel University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 to 65 years old
Be older than 18 years old
Timeline
Screening 1 weeks
Treatment 6 weeks
Follow Up 1 day
Awards & highlights
Study Summary
This trial evaluates how high-fat, sugar-filled ultra-processed foods may contribute to overeating and obesity. Results may help develop interventions to better treat these issues.
Who is the study for?
This trial is for adults aged 18-65 with obesity (BMI ≥ 30 kg/m2) who enjoy certain snack foods and can attend six sessions in Philadelphia. Participants must be able to use a smartphone. Exclusions include non-English speakers, recent significant weight loss or cardiovascular events, certain medication users, those with severe mood disorders or eating disorders, substance abuse issues, diabetes or hypertension diagnosis, and women who are nursing or pregnant.Check my eligibility
What is being tested?
The study investigates how different ingredients in ultra-processed foods (high in fat or refined carbohydrates) affect the body's reward responses and contribute to overeating and obesity. It aims to identify which aspects of these foods make them more likely to cause compulsive eating by examining physiological and metabolic reactions.See study design
What are the potential side effects?
Since this trial involves consumption of ultra-processed snacks rather than medication, traditional side effects are not applicable. However, participants may experience changes in appetite or weight due to the nature of the food consumed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Timeline
Screening ~ 1 weeks0 visits
Treatment ~ 6 weeks5 visits
Follow Up ~ 1 day1 visit
Screening ~ 1 weeks
Treatment ~ 6 weeks
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ad libitum consumption
Maturation-Promoting Factor
Daily calorie intake (EMA)
+2 moreSecondary outcome measures
Body Weight Changes
Magnitude of metabolic responses to food intake
Salivation responses to food intake
Other outcome measures
Individual risk factors for enhanced ultra-processed food reward
Trial Design
1Treatment groups
Experimental Treatment
Group I: Adults with obesityExperimental Treatment1 Intervention
All participants (n=50 adults with obesity) will complete each of the four food consumption appointments (order of the four appointments will be randomized/counterbalanced).
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Drexel UniversityLead Sponsor
150 Previous Clinical Trials
47,619 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a drug or alcohol addiction.I do not have or am unwilling to use a smartphone.You have lost more than 5% of your body weight in the past 6 months and this may affect your food preferences.I have had thoughts about suicide or attempted suicide in the past year.I am currently nursing, pregnant, or planning to become pregnant soon.I have had weight loss surgery in the past.I am currently trying to lose weight on my own or with a program.I am between 18 and 65 years old.I like the test snack foods at least a 6 out of 10.You have a body mass index (BMI) of 30 or higher.You are not able to speak, write, and read English fluently.I had a heart attack or stroke in the last year.I can and am willing to use a smartphone.I am currently taking medication that could affect my metabolism or appetite.I have been diagnosed with severe binge eating disorder or bulimia nervosa.I experience severe depression, anxiety, or thought disorders.I have diabetes with HbA1c over 6.5 or I have been told I have high blood pressure.You have told us that you are allergic to or do not like the snack foods that we will be testing.
Research Study Groups:
This trial has the following groups:- Group 1: Adults with obesity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Compulsive Eating Patient Testimony for trial: Trial Name: NCT05437809 — N/A
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