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Completed

NCT Number: NCT06518863

Ultra-Processed Foods and Executive Function

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.

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Key information

Conditions

Diet Habit Behavior Behavior, Animal Feeding Behavior

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Behavioral

Educational handouts on how to adhere to the corresponding diet.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. Body mass

    Time frame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

    Measured in kilograms

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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)

  21. 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)

  22. 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

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Registry information

Official study title

Elucidating the Relationship Between Ultra-Processed Food Consumption, Executive Function, and Hunger-Related Hormones

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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