Dietary Guidelines for Americans-Ultra Processed Study

NCT ID: NCT07252037

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2029-12-31

Brief Summary

The purpose of this research is to test how processing food can affect how one's body responds to it.

Detailed Description

The purpose of this project is to address the current gap in research on ultra-processed foods (UPFs) and cardiometabolic health with a feeding study that addresses the limitations of previously conducted intervention studies in matching UPF- and unprocessed- foods intervention diets for diet quality, nutrient content, and food type. Therefore, the primary objective is to evaluate diets composed primarily of ultra-processed or less processed foods that meet dietary guidelines recommendations on chronic disease risk factors. More specifically, when Dietary Guidelines for Americans (DGA)-compliant diets comprised of mostly ultra-processed and unprocessed foods (per Nova) are fed to generally healthy participants, determine whether there is an impact on:

• blood pressure
• fasting glucose and insulin concentrations, or
• lipid panel (total cholesterol, HDL-C, LDL-C, triglycerides).

Conditions

Overweight , Obesity; Class I Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Low-processed DGA Diet

Participants will be provided a Dietary Guidelines for Americans (DGA) compliant diet comprised of low-processed foods (Nova Categories 1-3)

Group Type: EXPERIMENTAL

Low-processed DGA Diet

Intervention Type: OTHER

Participants will consume a DGA menu made up of low-processed foods over a 4-week period

Ultra-processed DGA Diet

Participants will be provided a Dietary Guidelines for Americans (DGA) compliant diet comprised primarily of ultra-processed foods (Nova Category 4)

Group Type: EXPERIMENTAL

Ultra-processed DGA Diet

Intervention Type: OTHER

Participants will consume a DGA menu primarily made up of ultra-processed foods over a 4-week period

Interventions

Low-processed DGA Diet

Participants will consume a DGA menu made up of low-processed foods over a 4-week period

Intervention Type: OTHER

Ultra-processed DGA Diet

Participants will consume a DGA menu primarily made up of ultra-processed foods over a 4-week period

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI 18.5-34.9 kg/m2
• Systolic <139 mm Hg and Diastolic <90 mm Hg
• Able to understand and sign the consent form
• Have own transportation to the Grand Forks Human Nutrition Research Center
• Not allergic to study foods or unwilling to eat them
• Willing to comply with study demands
• Able to read and understand English

Exclusion Criteria

• Taking statins or medication to lower blood pressure,
• Taking anti-inflammatory or anti-diabetes medications
• Pregnant, lactating, or planning to become pregnant
• Diagnosed with an eating disorder
• Taking weight loss medications
• Smoke or use other tobacco products, including e-cigarettes
• Have overt hypothyroidism
• Diagnosed with cancer
• Exercise more than 30 minutes per day 2 or more days per week
• Allergic to study foods
• Express unwillingness to consume study foods at the screening appointment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USDA Grand Forks Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Julie Hess

Research Nutritionist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Hess, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Grand Forks Human Nutrition Research Center

Locations

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, United States

Countries

United States

Central Contacts

Julie Hess, PhD

Role: CONTACT

julie.hess@usda.gov

701-795-8146

Facility Contacts

Angela J Scheett, MPH, RD

Role: primary

angela.scheett@usda.gov

701-795-8386

Other Identifiers

GFHNRC158

Identifier Type: -

Identifier Source: org_study_id