Dietary Guidelines for Americans-Ultra Processed Study

NCT07252037 | Suspended

• 1 other identifier: GFHNRC158
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Class I Obesity; Overweight , Obesity

Keywords

Healthy Weight; Stage I Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean difference in systolic and diastolic blood pressure from baseline

  Mean difference in systolic and diastolic blood pressure from baseline

  Week 0, Week 4

Secondary Outcomes (2)

• Mean difference in fasting glucose and fasting insulin concentrations from baseline

  Week 0, Week 4

• Mean difference in fasting triglyceride concentrations from baseline

  Week 0, Week 4

Study Arms (2)

Low-processed DGA Diet

EXPERIMENTAL

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

Ultra-processed DGA Diet

EXPERIMENTAL

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

Interventions

Low-processed DGA Diet OTHER

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

Low-processed DGA Diet

Ultra-processed DGA Diet OTHER

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

Ultra-processed DGA Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Grand Forks Human Nutrition Research Center: lead

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Hypertension

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Julie Hess, PhD

  USDA Grand Forks Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nutritionist

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)