Dietary Guidelines for Americans-Ultra Processed Study (DGA-UP)

Impact of Dietary Guidelines Diets Containing Mostly Ultra-Processed Foods Compared to Less-Processed Foods on Biomarkers of Cardiometabolic Disease

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

Study Overview

• Status: Not yet recruiting
• Conditions: Class I Obesity; Overweight , Obesity
• Intervention / Treatment: Other: Low-processed DGA Diet; Other: Ultra-processed DGA Diet

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).

• Study Type: Interventional
• Enrollment (Estimated): 79
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Hess, PhD; Phone Number: 701-795-8146; Email: julie.hess@usda.gov

Study Locations

• United States
  • North Dakota
    • Grand Forks, North Dakota, United States, 58203
      • USDA Grand Forks Human Nutrition Research Center
      • Contact: Angela J Scheett, MPH, RD; Phone Number: 701-795-8386; Email: angela.scheett@usda.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: Low-processed DGA Diet; Participants will consume a DGA menu made up of low-processed foods over a 4-week period
Experimental: 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)	Other: Ultra-processed DGA Diet; Participants will consume a DGA menu primarily made up of ultra-processed foods over a 4-week period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in blood pressure from baseline	Week 0, Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in fasting and postprandial glucose and insulin concentrations from baseline	Week 0, Week 4
Change in lipid panel measures (total cholesterol, HDL-C, LDL-C, triglycerides) from baseline	Week 0, Week 4

Collaborators and Investigators

• Sponsor: USDA Grand Forks Human Nutrition Research Center
• Investigators: Principal Investigator: Julie Hess, PhD, USDA Grand Forks Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Stage I Hypertension; Healthy Weight
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Hypertension
• Other Study ID Numbers: GFHNRC158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No