(P07-26-26) DGA-UP Study Protocol: Impact of Dietary Guidelines Diets Containing Mostly Ultra Processed Foods Compared to Less-Processed Foods on Biomarkers of Cardiometabolic Disease

Objectives: Ultra-processed food (UPF) consumption has generated a great deal of concern due to its potential relationship with adverse health impacts. Evidence from intervention studies on the topic remains limited. Clinical trials published to date focus on comparing more- and less-processed diets, as defined by the Nova classification system, and their impact on weight-related outcomes. Only one trial compares equally healthful more- and less-processed diets. The Dietary Guidelines for Americans with Ultra-Processed foods (DGA-UP) study will be the first trial to examine whether there is a differential effect to following recommendations from the 2020-2025 Dietary Guidelines for Americans (2020 DGA) including more- or less-processed foods, as defined by Nova, on cardiometabolic disease risk factors.

Methods: A randomized controlled crossover dietary intervention study, DGA-UP will be conducted with 4 week provision of all meals to n=79 generally healthy male and female adults at eucaloric levels. The trial will consist of 2 dietary arms: 1) a less-processed 2020 DGA diet and 2) an ultra-processed 2020 DGA diet. Both interventions have excellent diet quality and contain similar amounts of macronutrients and micronutrients as well as the same types of food.

Results: The primary outcome is change in blood pressure from baseline to week 4. Fasting insulin and glucose as well as high sensitivity C-reactive protein, carotenoids, blood lipids, and complete blood count measures will be collected at regular intervals throughout the trial. Both diets contain amounts of macronutrients within the Acceptable Macronutrient Distribution Ranges and amounts of micronutrients within Dietary Reference Intakes. Sodium amounts exceed the Chronic Disease Risk Reduction recommendation, but the sodium amounts in the two diets are nearly equivalent (2542 mg and 2541 mg of sodium, respectively, on the less- and more-processed diets). Total sugar and saturated fat amounts are below 10% of total energy in both diets, and added sugar is ≤7% of total energy on both diets.

Conclusions: DGA-UP will help to fill a significant research gap regarding potential impact of UPFs on cardiometabolic health markers independent of food type, diet quality, and micronutrient content.

Funding Sources: USDA ARS