Determinants and Outcomes of High Vs. Low Ultra-processed Feeding

The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question[s] it aims to answer are:

• Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected.

If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Nutrition
• Intervention / Treatment: Other: Low-Processed Food Diet

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Stillwater, Oklahoma, United States, 74075
      • Laboratory for Applied Nutrition and Exercise Science (LANES)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• rural county resident
• not meeting physical activity guidelines for adults
• consuming a typical Western diet (rich in UPF)

Exclusion Criteria:

• chronic diseases
• tobacco, vape, or illicit drug use
• overly active
• already on a restrictive diet (e.g., keto, intermittent fasting)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Processed Food Group	Other: Low-Processed Food Diet; Participants that receive intervention will be instructed to eat a diet rich in unprocessed/minimally-processed foods, as described by the NOVA food classification system
No Intervention: Typical Diet Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Using a standard scale, body weight in kg will be assessed	1 year
Body Composition	Using Dual-energy X-ray absorptiometry(DXA), body composition will be assessed	1 year
Fat Mass Percentage	Using Dual-energy X-ray absorptiometry(DXA), fat mass percentage will be assessed	1 year
Fat-Free Mass Percentage	Using Dual-energy X-ray absorptiometry(DXA), fat-free mass will be assessed	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglyceride Levels	Blood draw followed by a Piccolo scan will analyze Triglyceride levels in the blood	1 year
Glucose Levels	Blood draw followed by a Piccolo scan will analyze glucose in the blood	1 year
Cholesterol Levels	Blood draw followed by a Piccolo scan will analyze glucose in the blood	1 year
HDL	Blood draw followed by a Piccolo scan will analyze HDL in the blood	1 year
LDL	Piccolo scan will analyze LDL in the blood	1 year
Alanine transaminase (ALT)	Blood draw followed by a Piccolo scan will analyze ALT in the blood	1 year
Aspartate transaminase (AST)	Blood draw followed by a Piccolo scan will analyze AST in the blood	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy Intake	3-Day Food Logs will record caloric intake at various points	1 year
Energy Expenditure	Resting Metabolic Rate will be used to find resting energy expenditure and an accelerometer will measure expended energy through fitness, combined these will show energy expenditure	1 year
Gut Microbiome Collection	Stool kits administered for fecal collection will be used for gut microbiome collection	1 year

Collaborators and Investigators

• Sponsor: Oklahoma State University
• Investigators: Principal Investigator: Sam Emerson, PhD, Oklahoma State University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): August 9, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB-23-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No