Ultra-processed Food Consumption and Health Pilot Study

Running, not enrolling · Not applicable

Conditions studied: Obesity & Overweight

In brief

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.

Key facts

Study ID

NCT07318064

Run by

Pennington Biomedical Research Center

People needed

6

Starts

2026-03-11

Expected to finish

2026-10-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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