NCT07318064Active, not recruiting
Ultra-processed Food Consumption and Health Pilot Study
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 19 Dec 2025
- Start date
- 11 Mar 2026
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Pennington Biomedical Research Center
- Diseases
- Obesity
- NCT number
- NCT07318064
What you commit to
- Study type: Interventional
- Planned participants: 6
- From 11 Mar 2026 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- 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
- Class II or higher congestive heart failure
- Unstable heart disease
- Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 weeks.
- 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
Lab values
- Hemoglobinopathy that interferes with measurement of HbA1c
Age
- Past bariatric surgery (\<10 years) - all types
Other
- Recent weight loss (≥10 pounds in the last six months)
- Given birth within the past year or is currently pregnant or breastfeeding
- Blood pressure ≥160/100 mm Hg
- Unwilling to stop alcohol intake during study participation
- Current smoker or other type of tobacco user (chewing tobacco, vaping, etc.)
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.