Ultra-Processed Foods and Executive Function
- Conditions
- Diet Habit
- 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
- Adults aged 18-55
- Willing to consume an entirely ultra-processed and entirely unprocessed diet for 3 days each (6 days in total)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Plasma ghrelin 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 Outcome Measures
Name Time Method Plasma C-peptide 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 active amylin 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 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 glucagon 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 insulin 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 leptin 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 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 secretin Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days) Measured in picograms per milliliter (pg/mL)
Body mass Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days) Measured in kilograms
Body mass index Measured 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 mass 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
Body fat mass 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
Percent lean mass 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
Lean mass 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
Food addiction according to the Yale Food Addiction Scale Version 2.0 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
Behavioral Inhibition System/Behavioral Approach System Scale 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
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 intake 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
Trial Locations
- Locations (1)
Oklahoma State University
🇺🇸Stillwater, Oklahoma, United States
Oklahoma State University🇺🇸Stillwater, Oklahoma, United States