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

Oklahoma State University

Status: Active, not recruiting

Conditions: Healthy Nutrition

Treatments: Other: Low-Processed Food Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06310603

IRB-23-42

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Low-Processed Food Group

Experimental group

Treatment:

Other: Low-Processed Food Diet

Typical Diet Group

No Intervention group