Dietary Guidelines for Americans-Ultra Processed Study

N/ANot Yet RecruitingNCT07252037

USDA Grand Forks Human Nutrition Research Center79 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Overweight , Obesity Class I Obesity

Interventions

Low-processed DGA DietOTHER

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

Ultra-processed DGA DietOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, United States

Outcomes

Primary Outcomes

Change in blood pressure from baseline

Time frame: Week 0, Week 4

Secondary Outcomes

Change in fasting and postprandial glucose and insulin concentrations from baseline

Time frame: Week 0, Week 4

Change in lipid panel measures (total cholesterol, HDL-C, LDL-C, triglycerides) from baseline

Time frame: Week 0, Week 4

Central Contacts

Julie Hess, PhD

CONTACT

701-795-8146 julie.hess@usda.gov

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.