Diet Habit
Conditions
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.
Interventions
BEHAVIORALEducation
Educational handouts on how to adhere to the corresponding diet.
Sponsors
Oklahoma State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 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 |
| 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) |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed