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NCT Number: NCT07252037

Dietary Guidelines for Americans-Ultra Processed Study

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

Why the study stopped: Change in administrative priorities. Protocol has been published, but recruitment never started.
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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-processed DGA Diet

Other

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

Ultra-processed DGA Diet

Other

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

Primary outcomes

  1. Mean difference in systolic and diastolic blood pressure from baseline

    Time frame: Week 0, Week 4

    Mean difference in systolic and diastolic blood pressure from baseline

Secondary outcomes

  1. Mean difference in fasting glucose and fasting insulin concentrations from baseline

    Time frame: Week 0, Week 4

    Mean difference in fasting glucose and fasting insulin concentrations from baseline

  2. Mean difference in fasting triglyceride concentrations from baseline

    Time frame: Week 0, Week 4

    Mean difference in fasting triglyceride concentrations from baseline

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Registry information

Official study title

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

Acronym: DGA-UP

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 26, 2025
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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