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

NCT ID: NCT06310603

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-09
• Study Completion Date: 2025-08-09

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.

Conditions

Healthy Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Low-Processed Food Group

Group Type: EXPERIMENTAL

Low-Processed Food Diet

Intervention Type: OTHER

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

Typical Diet Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oklahoma State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Emerson, PhD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University

Locations

Laboratory for Applied Nutrition and Exercise Science (LANES)

Stillwater, Oklahoma, United States

Countries

United States

Other Identifiers

IRB-23-42

Identifier Type: -

Identifier Source: org_study_id