Clinical trial NCT06518863: Ultra-Processed Foods and Executive Function
Official title: Elucidating the Relationship Between Ultra-Processed Food Consumption, Executive Function, and Hunger-Related Hormones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet Habit
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma ghrelin
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Secondary outcomes:
measure: Plasma active amylin
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Plasma C-peptide
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Plasma active glucagon-like peptide-1 (GLP-1)
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Plasma gastric inhibitory polypeptide (GIP)
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Plasma glucagon
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Plasma insulin
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Plasma leptin
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Plasma monocyte chemoattractant protein-1 (MCP-1)
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Plasma pancreatic polypeptide (PP)
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Plasma peptide YY (PYY)
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Plasma secretin
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Body mass
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Body mass index
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Percent fat mass
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Body fat mass
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Percent lean mass
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Lean mass
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Food addiction according to the Yale Food Addiction Scale Version 2.0
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Behavioral Inhibition System/Behavioral Approach System Scale
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Executive Function: Tower Test (Delis-Kaplan Executive Function System)
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System)
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
measure: Ultra-processed food intake
timeFrame: Measured at three times: baseline, post-first diet arm (3 days), post-second diet arm (6 days)
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
References: