Ultra-processed Food Consumption and Health Pilot Study | Clinical Trial | StuddyBuddy@endsection Ultra-processed Food Consumption and Health Pilot Study
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Recruiting NCT07318064

Ultra-processed Food Consumption and Health Pilot Study

Conditions: Obesity & Overweight

Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 6
Sponsor: Pennington Biomedical Research Center

Location: Pennington Biomedical Research Center Baton Rouge Louisiana

Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 (\

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07318064). StuddyBuddy aggregates publicly available trial information.