Ultra-Processed Foods and Executive Function

NCT06518863 | Completed

• 1 other identifier: IRB-23-322-STW
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Habit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Plasma active amylin

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

• Plasma C-peptide

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

• Plasma gastric inhibitory polypeptide (GIP)

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

• Plasma glucagon

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

Study Arms (2)

Ultra-processed foods

EXPERIMENTAL

Participants are instructed to consume only ultra-processed foods for 3 days.

Behavioral: Education

Unprocessed foods

EXPERIMENTAL

Participants are instructed to consume only unprocessed foods for 3 days.

Behavioral: Education

Interventions

Education BEHAVIORAL

Educational handouts on how to adhere to the corresponding diet.

Ultra-processed foods; Unprocessed foods

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-55
• Willing to consume an entirely ultra-processed and entirely unprocessed diet for 3 days each (6 days in total)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: July 24, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)