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Processed vs Minimally Processed Foods for Metabolic Health (PFR Trial)

N/A
Recruiting
Research Sponsored by Virginia Polytechnic Institute and State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 weeks
Awards & highlights

PFR Trial Summary

This trial will test if ultra-processed foods have a greater reward response than minimally processed foods and if this is reflected in the brain.

Who is the study for?
This trial is for English-speaking adults with a BMI of 18.5-24.9, living near Roanoke, who can see a computer screen clearly and are not pregnant. Excluded are those with MRI contraindications like pacemakers, metal implants, claustrophobia; history of significant head injury; metabolic disorders including diabetes or thyroid issues; substance dependence; active neurological conditions; eating disorders or food allergies.Check my eligibility
What is being tested?
The study compares the body's response to minimally processed foods (MPFs) versus ultra-processed foods (UPFs). Participants will eat meals from both categories in a controlled setting while their metabolic responses are measured. They'll also bid on these foods in an MRI scanner to assess brain activity related to food value perception.See study design
What are the potential side effects?
Since this trial involves consuming regular meals and undergoing MRI scans, side effects may include discomfort from lying still during scans for some individuals. There might be mild digestive differences when switching between MPF and UPF diets.

PFR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood glucose response to level of food processing
Blood insulin response to level of food processing
Effect of food processing on food value and encoding
+3 more

PFR Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Stimulus: UPF3Experimental Treatment6 Interventions
In a whole room metabolic chamber participants will consume a ~300 kcal meal consisting of ultra-processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).
Group II: Stimulus: UPF2Experimental Treatment6 Interventions
In a whole room metabolic chamber participants will consume a ~300 kcal meal consisting of ultra-processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).
Group III: Stimulus: UPF1Experimental Treatment6 Interventions
In a whole room metabolic chamber participants will consume a ~300 kcal meal consisting of ultra-processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).
Group IV: Stimulus: MPF1Active Control6 Interventions
In a whole room metabolic chamber participants will consume a ~300 kcal meal consisting of minimally processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).
Group V: Stimulus: MPF3Active Control6 Interventions
In a whole room metabolic chamber participants will consume a ~300 kcal meal consisting of minimally processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).
Group VI: Stimulus: MPF2Active Control6 Interventions
In a whole room metabolic chamber participants will consume a ~300 kcal meal consisting of minimally processed foods as determined by the widely used NOVA scale. The whole room metabolic chamber will allow for collection of simultaneous measurement of multiple metabolic responses (glucose, insulin, and metabolic rate). Measures will be collected for 45 min before consumption of the meal (baseline) and for 3 hours after consumption (post-prandial).

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Who is running the clinical trial?

Virginia Polytechnic Institute and State UniversityLead Sponsor
143 Previous Clinical Trials
27,739 Total Patients Enrolled

Frequently Asked Questions

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

Are participants aged 35 or older permissible for inclusion in this experiment?

"This clinical trial is geared towards individuals aged 18 to 45. For those younger than 18, 28 studies are available while 78 trials target patients above 65 years of age."

Answered by AI

What is the total sample size of this experimentation?

"Indeed, the clinicaltrial.gov website affirms that this medical trial is still actively seeking candidates. The study was originally posted on July 1st of 2023 and has been updated most recently on August 24th of the same year. At present, 74 prospective participants are needed to be enrolled from a single site."

Answered by AI

Is there availability in this research study for potential participants?

"Affirmative, the information on clinicaltrials.gov attests to this trial's active recruitment of participants. As per records, it was initially published on July 1st 2023 and underwent recent revisions in late August 2023. This research necessitates 74 individuals from a single medical site."

Answered by AI

What type of individual is most suitable to partake in this experiment?

"To be eligible for this medical trial, candidates must have a metabolic disorder and fit within the age range of 18 to 45. Currently, 74 participants are being sought."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effect of Processing on Food Reward
Alexandra DiFeliceantonio 2023. "The Effect of Processing on Food Reward". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06017986.
~43 spots leftby Jul 2025
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