Skip to content

Dietary Guidelines for Americans-Ultra Processed Study

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07252037
Acronym
DGA-UP
Enrollment
0
Registered
2025-11-26
Start date
2026-12-01
Completion date
2029-12-01
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class I Obesity, Overweight , Obesity

Keywords

Healthy Weight, Stage I Hypertension

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).

Interventions

OTHERLow-processed DGA Diet

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

OTHERUltra-processed DGA Diet

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

Sponsors

USDA Grand Forks Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean difference in systolic and diastolic blood pressure from baselineWeek 0, Week 4Mean difference in systolic and diastolic blood pressure from baseline

Secondary

MeasureTime frameDescription
Mean difference in fasting glucose and fasting insulin concentrations from baselineWeek 0, Week 4Mean difference in fasting glucose and fasting insulin concentrations from baseline
Mean difference in fasting triglyceride concentrations from baselineWeek 0, Week 4Mean difference in fasting triglyceride concentrations from baseline

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJulie Hess, PhD

USDA Grand Forks Human Nutrition Research Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026