Ultra-processed Food Consumption and Health Pilot Study
Eligible age
18–50 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
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About this 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.
Sponsor: Pennington Biomedical Research Center
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Baton Rouge
Source: ClinicalTrials.gov · NCT07318064 · last updated 2026-06-04