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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

Must not have

Current diagnosis of type 1 or 2 diabetes (HbA1c > 6.5; will be confirmed by blood test at baseline) or self-reported diagnosis of hypertension

Self-report a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months

Timeline

Screening 1 week

Treatment 6 weeks

Follow Up 1 day

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am between 18 and 65 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 with HbA1c over 6.5 or I have been told I have high blood pressure.

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I had a heart attack or stroke in the last year.

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I experience severe depression, anxiety, or thought disorders.

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I have been diagnosed with severe binge eating disorder or bulimia nervosa.

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I have had thoughts about suicide or attempted suicide in the past year.

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I have had weight loss surgery in the past.

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I am currently trying to lose weight on my own or with a program.

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I am currently nursing, pregnant, or planning to become pregnant soon.

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I do not have or am unwilling to use a smartphone.

Timeline

Screening ~ 1 week0 visits

Treatment ~ 6 weeks5 visits

Follow Up ~ 1 day1 visit

Screening ~ 1 week

Treatment ~ 6 weeks

Follow Up ~1 day

This trial's timeline: 1 week for screening, 6 weeks for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ad libitum consumption

Maturation-Promoting Factor

Daily calorie intake (EMA)

+2 more

Secondary study objectives

Body Weight Changes

Magnitude of metabolic responses to food intake

Salivation responses to food intake

Other study objectives

Individual risk factors for enhanced ultra-processed food reward

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 10Eligibility criteria met