Determinants and Outcomes of High vs. Low Ultra-processed Feeding
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 9, 2023
CompletedFirst Submitted
Initial submission to the registry
December 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2025
CompletedMarch 20, 2025
March 1, 2025
1.8 years
December 13, 2023
March 17, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (7)
Triglyceride Levels
1 year
Glucose Levels
1 year
Cholesterol Levels
1 year
HDL
1 year
LDL
1 year
- +2 more secondary outcomes
Other Outcomes (3)
Energy Intake
1 year
Energy Expenditure
1 year
Gut Microbiome Collection
1 year
Study Arms (2)
Low-Processed Food Group
EXPERIMENTALTypical Diet Group
NO INTERVENTIONInterventions
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
Eligibility Criteria
You may qualify if:
- rural county resident
- not meeting physical activity guidelines for adults
- consuming a typical Western diet (rich in UPF)
You may not qualify if:
- chronic diseases
- tobacco, vape, or illicit drug use
- overly active
- already on a restrictive diet (e.g., keto, intermittent fasting)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory for Applied Nutrition and Exercise Science (LANES)
Stillwater, Oklahoma, 74075, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Sam Emerson, PhD
Oklahoma State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2023
First Posted
March 15, 2024
Study Start
August 9, 2023
Primary Completion
May 31, 2025
Study Completion
August 9, 2025
Last Updated
March 20, 2025
Record last verified: 2025-03