Ultra-processed Food Consumption and Health Pilot Study

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Pennington Biomedical Research Center
Study ID
NCT07318064
Status
Recruiting
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Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Purple Diet — BEHAVIORAL
    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.
  • Ultra-processed diet — BEHAVIORAL
    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.

Study Details

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 Dates

Start date
Mar 11, 2026
Status verified
Jun 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
6 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Active Comparator: Purple 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. The Purple Diet has been used in the Nutrition for Precision Health study.
  • Experimental: Ultra-processed Diet
    The ultra-processed (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.

Primary Outcome Measure

Body weight [ Time Frame: Change from baseline to 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIP
Pennington Biomedical Research CenterBaton RougeLouisiana70810

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