Ultra-processed Food Consumption and Health Pilot Study

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.

NCT Number	NCT07318064
Lead Sponsor	Pennington Biomedical Research Center
Conditions	Obesity & Overweight
Enrollment	6 participants
Start Date	2026-03-11
Primary Completion	2026-10-01 (estimated)
Study Completion	2026-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-29