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Ultra-Processed Foods and Executive Function

Not Applicable
Recruiting
Conditions
Diet Habit
Interventions
Behavioral: Education
Registration Number
NCT06518863
Lead Sponsor
Oklahoma State University
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
20
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)
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Ultra-processed foodsEducationParticipants are instructed to consume only ultra-processed foods for 3 days.
Unprocessed foodsEducationParticipants are instructed to consume only unprocessed foods for 3 days.
Primary Outcome Measures
NameTimeMethod
Plasma ghrelinMeasured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in picograms per milliliter (pg/mL)

Secondary Outcome Measures
NameTimeMethod
Plasma C-peptideMeasured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in picograms per milliliter (pg/mL)

Plasma active glucagon-like peptide-1 (GLP-1)Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in picograms per milliliter (pg/mL)

Plasma gastric inhibitory polypeptide (GIP)Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in pg/mL

Plasma glucagonMeasured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in picograms per milliliter (pg/mL)

Plasma insulinMeasured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in picograms per milliliter (pg/mL)

Plasma leptinMeasured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in picograms per milliliter (pg/mL)

Plasma monocyte chemoattractant protein-1 (MCP-1)Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in picograms per milliliter (pg/mL)

Plasma pancreatic polypeptide (PP)Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in picograms per milliliter (pg/mL)

Plasma peptide YY (PYY)Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in picograms per milliliter (pg/mL)

Plasma secretinMeasured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in picograms per milliliter (pg/mL)

Body massMeasured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in kilograms

Body mass indexMeasured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in kilograms divided by meters squared

Percent fat massMeasured 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

Body fat massMeasured 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

Percent lean massMeasured 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

Lean massMeasured 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

Food addiction according to the Yale Food Addiction Scale Version 2.0Measured 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

Plasma active amylinMeasured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)

Measured in picograms per milliliter (pg/mL)

Behavioral Inhibition System/Behavioral Approach System ScaleMeasured 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

Executive Function: Tower Test (Delis-Kaplan Executive Function System)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)

Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System)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)

Ultra-processed food intakeMeasured 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

Trial Locations

Locations (1)

Oklahoma State University

🇺🇸

Stillwater, Oklahoma, United States

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