RecruitingNot ApplicableNCT07318064

Ultra-processed Food Consumption and Health Pilot Study

Sponsor

Pennington Biomedical Research Center

Enrollment

6 participants

Start Date

Mar 11, 2026

Study Type

INTERVENTIONAL

Conditions

Obesity, Overweight

Summary

The objective of this study is to explore the effects of two dietary conditions (UPF-diet and typical American diet) on a number of clinical and metabolic outcomes in order to derive sample size estimates for a larger trial and to determine the feasibility of the study approach. This study is an out-patient cross-over trial comparing the Nutrition for Precision Health (NPH) purple diet (American Diet) and a diet high in ultra-processed foods (UPF diet) for two weeks in which participants will be randomized to the order of the diets. Specific Aim 1: Determine the feasibility of recruiting, enrolling and assessing participants in a randomized trial comparing a UPF diet with the standard American diet. Feasibility will be assessed by the achievement of study goals (i.e., sample size; completeness of study data). Specific Aim 2: Derive sample size estimates for future trials based on the mean effects and associated variances obtained in the pilot study.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria5

Overweight or obesity (BMI 25-50 kg/m2)
Willingness to accept group assignment and provide outcome measures
Premenopausal (women only)
Be able to communicate (oral and written) in English
Be able to provide informed consent

Exclusion Criteria19

Recent weight loss (≥10 pounds in the last six months)
On a regimen of medications (weight loss or otherwise) that can affect weight or diabetes outcomes for less than 3 months (GLP1 medications allowed if weight stable and on stable dose for >=3 months)
Given birth within the past year or is currently pregnant or breastfeeding
Past bariatric surgery (<10 years) - all types
Disease/condition that is life threatening or can interfere with or be aggravated by weight change
Dementia, psychiatric illness, or substance abuse that may interfere with adherence
Current or history of a clinically diagnosed eating disorder, including anorexia nervosa or bulimia nervosa
Type 1 or type 2 diabetes
Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease
Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Exceptions include 1) successfully resected non-melanoma carcinoma of the skin, 2) basal or squamous cell skin cancer, 3) stage 0 non-invasive carcinoma of the cervix, 4) stage 0 non-invasive prostate cancer
History of kidney or liver disease or malnutrition that in investigator judgment should exclude participation
Hemoglobinopathy that interferes with measurement of HbA1c
Class II or higher congestive heart failure
Unstable heart disease
Blood pressure ≥160/100 mm Hg
Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 weeks.
Unwilling to stop alcohol intake during study participation
Current smoker or other type of tobacco user (chewing tobacco, vaping, etc.)
Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALPurple Diet

The Purple Diet is modeled after a typical American diet which is popular, widely available, and lower in cost compared to other diets. However, the diet is high in total fat, and particularly in saturated fat, with consumption far exceeding 10% of total energy intake. Intake of added sugars also far exceeds the recommended limits.

BEHAVIORALUltra-processed diet

The ultra-processed food (UPF) diet is designed to contain approximately 75% of energy from ultra-processed foods. Foods and ingredients in the ultra-processed diet consist of those defined in the NOVA classification as "ultra-processed" (group 4 of the classification). The NOVA classification groups foods according to the nature, extent and purpose of the industrial processing they undergo.10 In the NOVA classification, ultra-processed foods include such things as soft drinks, packaged snacks, reconstituted meat products and pre-prepared frozen dishes, and are made mostly or entirely from substances derived from foods and additives, with little if any unprocessed foods.