Ultra-Processed Foods and Executive Function
NCT Number: NCT06518863
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diet Habit
Interventions: BEHAVIORAL: Education
Sponsor: Oklahoma State University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-01-01
Completion Date: 2025-06-30
Locations: Oklahoma State University, Stillwater, Oklahoma, 74078, United States

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.

Primary Outcome Measures: Plasma ghrelin, 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: Plasma active amylin, 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, 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), 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), Measured in pg/mL, 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 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 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 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 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 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 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 at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)|Body mass, Measured in pounds and kilograms, 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 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 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 pounds and kilograms, 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 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 pounds and kilograms, 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 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 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 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 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 at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)