Diet HabitNCT06518863
Ultra-Processed Foods and Executive Function
A study testing Education in people with Diet Habit, run by Oklahoma State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-55
- Willing to consume an entirely ultra-processed and entirely unprocessed diet for 3 days each (6 days in total)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University
Stillwater, Oklahoma, 74078
About this study
Official title: 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.
- Conditions
- Diet Habit
- Being tested
- Education
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Educational handouts on how to adhere to the corresponding diet.
| Study group | Role | What they receive |
|---|---|---|
| Ultra-processed foods | Experimental | Participants are instructed to consume only ultra-processed foods for 3 days. Receives: Behavioral: Education |
| Unprocessed foods | Experimental | Participants are instructed to consume only unprocessed foods for 3 days. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma ghrelin
Measured in picograms per milliliter (pg/mL)
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Secondary outcomes (22)
Plasma active amylin
Measured in picograms per milliliter (pg/mL)
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Plasma C-peptide
Measured in picograms per milliliter (pg/mL)
Measured: 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)
Measured in picograms per milliliter (pg/mL)
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Plasma gastric inhibitory polypeptide (GIP)
Measured in pg/mL
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Plasma glucagon
Measured in picograms per milliliter (pg/mL)
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Plasma insulin
Measured in picograms per milliliter (pg/mL)
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Plasma leptin
Measured in picograms per milliliter (pg/mL)
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Plasma monocyte chemoattractant protein-1 (MCP-1)
Measured in picograms per milliliter (pg/mL)
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Plasma pancreatic polypeptide (PP)
Measured in picograms per milliliter (pg/mL)
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Plasma peptide YY (PYY)
Measured in picograms per milliliter (pg/mL)
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Plasma secretin
Measured in picograms per milliliter (pg/mL)
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Body mass
Measured in kilograms
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Body mass index
Measured in kilograms divided by meters squared
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Percent fat mass
Measured using a seca medical body composition analyzer (mBCA) 514 bioelectrical impedance scale, as a percentage
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Body fat mass
Measured using a seca medical body composition analyzer (mBCA) 514 bioelectrical impedance scale, in kilograms
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Percent lean mass
Measured using a seca medical body composition analyzer (mBCA) 514 bioelectrical impedance scale, as a percetange
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Lean mass
Measured using a seca medical body composition analyzer (mBCA) 514 bioelectrical impedance scale, in kilograms
Measured: 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
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: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Behavioral Inhibition System/Behavioral Approach System Scale
Score ranges from 20 to 80, with higher scores indicating greater behavioral inhibition and behavioral activation
Measured: 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)
Total Achievement Score (range=0-30, higher = higher executive function)
Measured: 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)
Scaled inhibition/switching scores (score range=1-19, higher = higher executive function)
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Ultra-processed food intake
Measured as a percent of total calories, taken from 3-day diet records
Measured: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Jan 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518863
- Sponsor's protocol ID
- IRB-23-322-STW
- Status last verified
- Feb 2026
- First submitted
- 16 May 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Relationship Between Ultra-Processed Food Consumption, Executive Function, and Hunger-Related Hormones
- ClinicalTrials.gov ID
- NCT06518863
- Acronym / sponsor ID
- IRB-23-322-STW
- Conditions
- Diet Habit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra-processed foods | Experimental | Behavioral: EducationParticipants are instructed to consume only ultra-processed foods for 3 days. |
| Unprocessed foods | Experimental | Behavioral: EducationParticipants are instructed to consume only unprocessed foods for 3 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged 18-55
- Willing to consume an entirely ultra-processed and entirely unprocessed diet for 3 days each (6 days in total)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationEducational handouts on how to adhere to the corresponding diet. | Behavioural | Ultra-processed foods, Unprocessed foods |
Primary outcome
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)
22 secondary outcomes
Plasma active amylin
Time frame: 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)
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)
Plasma gastric inhibitory polypeptide (GIP)
Time frame: 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)
Plasma insulin
Time frame: 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)
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)
Plasma pancreatic polypeptide (PP)
Time frame: 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)
Plasma secretin
Time frame: 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)
Body mass index
Time frame: 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)
Body fat mass
Time frame: 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)
Lean mass
Time frame: 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)
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)
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)
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)
Ultra-processed food intake
Time frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Diet Habit, run by Oklahoma State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma ghrelin (time frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.