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

Not Applicable

Recruiting

• Conditions: Healthy Nutrition
• Interventions: Other: Low-Processed Food Diet

• Registration Number: NCT06310603
• Lead Sponsor: Oklahoma State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-09
• Study First Submitted: 2023-12-13
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-06
• Last Update Submitted: 2024-03-06
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-05-15
• Study Completion: 2025-08-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Processed Food Group	Low-Processed Food Diet	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Laboratory for Applied Nutrition and Exercise Science (LANES); 🇺🇸 Stillwater, Oklahoma, United States