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

USDA Grand Forks Human Nutrition Research Center

Status: Not yet enrolling

Conditions: Overweight , Obesity; Class I Obesity

Treatments: Other: Ultra-processed DGA Diet; Other: Low-processed DGA Diet

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07252037

GFHNRC158

Details and patient eligibility

About

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

Full 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).

Enrollment: 79 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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79 participants in 2 patient groups

Low-processed DGA Diet

Experimental group

Description:

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

Treatment:

Other: Low-processed DGA Diet

Ultra-processed DGA Diet

Experimental group

Description:

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

Treatment:

Other: Ultra-processed DGA Diet