High Ultra Processed Food Diet for Eating Behaviors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fralin Biomedical Research Institute at VTC, Roanoke, VA
Eating Behaviors+1 More
High Ultra Processed Food Diet - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

Most individuals with obesity become so before age 35 and adolescent's unhealthy dietary patterns, specifically high intake of ultra-processed foods and poor overall diet quality, may contribute to energy overconsumption and weight gain. The overall objective of this research is to establish proof-of-concept for altered reward processing measured by brain response to ultra-processed foods, an increase in ad libitum energy intake, and adverse effects on executive function in response to an ultra-processed diet (81% total energy) compared to a diet emphasizing minimally processed foods in individuals aged 18-25 years.

Eligible Conditions

  • Eating Behaviors
  • Eating Habits

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 2 measurements following the 2-week UPF diet (day 15), following the 2-week no UPF diet (day 15)

2 measurements (following the 2-week UPF diet, following the 2-week no UPF diet)
Change in amount of energy (kcals) selected from 2 weeks high UPF or 2 weeks no UPF diet
Change in food items selected from 2 weeks high UPF or 2 weeks no UPF diet
Change in grams of food selected from 2 weeks high UPF or 2 weeks no UPF diet
Change in internal state ratings from 2 weeks high UPF or 2 weeks no UPF diet
Day 15
Change in eating rate from 2 weeks high UPF or 2 weeks no UPF diet
Change in energy intake from 2 weeks high UPF or 2 weeks no UPF diet
4 measurements (in person and take home portion following the 2-week UPF diet, in person and take home portion following the 2-week no UPF diet)
Change in eating in the absence of hunger from baseline to 2-weeks post high UPF or 2 weeks no UPF diet
4 measurements (pre/post 2-week UPF diet, pre/ post 2-week no UPF diet)
Change in brain response from baseline to 2-weeks post high UPF or 2 weeks no UPF diet
Change in executive function from baseline to 2-weeks post high UPF or 2 weeks no UPF diet

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

High Ultra Processed Food Diet
1 of 2
No Ultra Processed Food Diet
1 of 2
Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: High Ultra Processed Food Diet · No Placebo Group · N/A

High Ultra Processed Food Diet
Other
Experimental Group · 1 Intervention: High Ultra Processed Food Diet · Intervention Types: Other
No Ultra Processed Food Diet
Other
Experimental Group · 1 Intervention: No Ultra Processed Food Diet · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 measurements following the 2-week upf diet (day 15), following the 2-week no upf diet (day 15)
Closest Location: Fralin Biomedical Research Institute at VTC · Roanoke, VA
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2019First Recorded Clinical Trial
1 TrialsResearching Eating Behaviors
5 CompletedClinical Trials

Who is running the clinical trial?

Virginia Polytechnic Institute and State UniversityLead Sponsor
108 Previous Clinical Trials
25,502 Total Patients Enrolled
Alexandra G DiFeliceantonio, PhDPrincipal InvestigatorVirginia Polytechnic Institute and State University
Brenda M Davy, PhD, RDNPrincipal InvestigatorVirginia Polytechnic Institute and State University

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have no plans to gain/lose weight or change physical activity level.
You are willing to consume food provided for two 14-day periods.
You have a score of 11 or less on the TFEQ cognitive restraint scale.
You have a usual diet that is higher than the average of US adolescents.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.