Ultra-Processed Foods and Executive Function
February 2, 2026 updated by: Oklahoma State University
Elucidating the Relationship Between Ultra-Processed Food Consumption, Executive Function, and Hunger-Related Hormones
The purpose of this study is to examine potential effects of a diet characterized by UPF on hunger-related hormones and executive function.
It entails a two-arm, crossover, randomized controlled trial.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Stillwater, Oklahoma, United States, 74078
- Oklahoma State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults aged 18-55
- Willing to consume an entirely ultra-processed and entirely unprocessed diet for 3 days each (6 days in total)
Exclusion Criteria:
- Chronic disease that interferes with study-related activities
- Special diet that limits adherence to the intervention diets
- Visual impairment not corrected by glasses/contacts
- Pregnant or lactating
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ultra-processed foods
Participants are instructed to consume only ultra-processed foods for 3 days.
|
Educational handouts on how to adhere to the corresponding diet.
|
|
Experimental: Unprocessed foods
Participants are instructed to consume only unprocessed foods for 3 days.
|
Educational handouts on how to adhere to the corresponding diet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma ghrelin
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in picograms per milliliter (pg/mL)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma active amylin
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in picograms per milliliter (pg/mL)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Plasma C-peptide
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in picograms per milliliter (pg/mL)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Plasma active glucagon-like peptide-1 (GLP-1)
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in picograms per milliliter (pg/mL)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Plasma gastric inhibitory polypeptide (GIP)
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in pg/mL
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Plasma glucagon
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in picograms per milliliter (pg/mL)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Plasma insulin
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in picograms per milliliter (pg/mL)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Plasma leptin
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in picograms per milliliter (pg/mL)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Plasma monocyte chemoattractant protein-1 (MCP-1)
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in picograms per milliliter (pg/mL)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Plasma pancreatic polypeptide (PP)
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in picograms per milliliter (pg/mL)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Plasma peptide YY (PYY)
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in picograms per milliliter (pg/mL)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Plasma secretin
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in picograms per milliliter (pg/mL)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Body mass index
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in kilograms divided by meters squared
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Percent fat mass
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured using a seca medical body composition analyzer (mBCA) 514 bioelectrical impedance scale, as a percentage
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Percent lean mass
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured using a seca medical body composition analyzer (mBCA) 514 bioelectrical impedance scale, as a percetange
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Food addiction according to the Yale Food Addiction Scale Version 2.0
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Presented as a symptom count (score range from 0-11, higher means more food addiction symptoms) and used to classify as "No," "Mild," "Moderate," or "Severe" food addiction
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Behavioral Inhibition System/Behavioral Approach System Scale
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Score ranges from 20 to 80, with higher scores indicating greater behavioral inhibition and behavioral activation
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Executive Function: Tower Test (Delis-Kaplan Executive Function System)
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Total Achievement Score (range=0-30, higher = higher executive function)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System)
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Scaled inhibition/switching scores (score range=1-19, higher = higher executive function)
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Ultra-processed food intake
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured as a percent of total calories, taken from 3-day diet records
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Body mass
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured in kilograms
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Body fat mass
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured using a seca medical body composition analyzer (mBCA) 514 bioelectrical impedance scale, in kilograms
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
|
Lean mass
Time Frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Measured using a seca medical body composition analyzer (mBCA) 514 bioelectrical impedance scale, in kilograms
|
Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
October 1, 2024
Study Completion (Actual)
October 1, 2024
Study Registration Dates
First Submitted
May 16, 2024
First Submitted That Met QC Criteria
July 18, 2024
First Posted (Actual)
July 24, 2024
Study Record Updates
Last Update Posted (Actual)
February 4, 2026
Last Update Submitted That Met QC Criteria
February 2, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-23-322-STW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.