Ultra-processed Food Consumption and Health Pilot Study
Pennington Biomedical Research Center
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.
Description
The investigators will conduct an out-patient cross-over trial comparing the Nutrition for Precision Health (NPH) purple diet and a diet high in ultra-processed foods (UPF diet) with participants randomized equally to one of two conditions. Assessments of study outcomes will be conducted at baseline prior to randomization, and pre- and post- each dietary condition. The overarching aim is to determine the feasibility of the study approach, and to explore the effects of the dietary conditions on a number of clinical and metabolic outcomes. Participants in this study will be 6 adults (both males…
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- BehavioralPurple Diet
The Purple Diet is modeled after a typical American diet which is popular, widely available, and lower in cost compared to other diets. However, the diet is high in total fat, and particularly in saturated fat, with consumption far exceeding 10% of total energy intake. Intake of added sugars also far exceeds the recommended limits.
- BehavioralUltra-processed diet
The ultra-processed food (UPF) diet is designed to contain approximately 75% of energy from ultra-processed foods. Foods and ingredients in the ultra-processed diet consist of those defined in the NOVA classification as "ultra-processed" (group 4 of the classification). The NOVA classification groups foods according to the nature, extent and purpose of the industrial processing they undergo.10 In the NOVA classification, ultra-processed foods include such things as soft drinks, packaged snacks, reconstituted meat products and pre-prepared frozen dishes, and are made mostly or entirely from substances derived from foods and additives, with little if any unprocessed foods.
Location
- Pennington Biomedical Research CenterBaton Rouge, Louisiana