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Ultra-processed Food Consumption and Health Pilot Study

Study acronym: ULTRA PIlot
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 29, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised
    v4
  2. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 1, 2026 to Mar 11, 2026
    v3
  3. Study description expanded, about 1 wordv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07318064
Lead Sponsor Pennington Biomedical Research Center
Conditions
(from sponsor)		 Obesity & Overweight
Related terms Obesity, Overweight, Weight Loss
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov