Ultra-processed Food Consumption and Health Pilot Study (NCT07318064)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Pennington Biomedical Research Center — Baton Rouge, Louisiana
Age range: 18 Years to 50 Years
🧪 Interventions in This Study
- Purple Diet (BEHAVIORAL)
- Ultra-processed diet (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Pennington Biomedical Research Center — Baton Rouge, Louisiana
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.