#2481 Reduction in ultra-processed food by providing medically tailored healthy food baskets to patients with CKD: the HELPFUL trial
Authors: Avesani Carla Maria , Cecchini Valeria , Heimbürger Olof , Sallstrom Torsten , Rubin Charlotta , Canella Daniela , Lindholm Bengt , Stenvinkel Peter 
Published: May 2024

Abstract

Background and Aims
Over the past decade, there has been a growing interest in classifying foods based on the extent and purpose of industrial processing according to the NOVA system, which outlines four main food categories: unprocessed and minimally processed foods, processed culinary ingredients, processed foods, and ultra-processed foods (UPFs). The latter is characterized by industrial formulations with an elevated content of additives, sugar, unhealthy fat, and sodium. Increased consumption of UPFs can worsen metabolic derangements that develop as kidney function decreases in patients with chronic kidney disease (CKD). We evaluated food intake according to the NOVA food classification system before and after a medically tailored meal intervention with plant-based food baskets for patients with CKD who had hyperkalemia at inclusion and received sodium zirconium cyclosilicate (SZC) to normalize plasma potassium. Additionally, we aimed to assess the diets’ environmental impact by evaluating the greenhouse gas emissions (GHGE) associated with these dietary changes.

Method
Data were based on a six-week feasibility one-arm clinical study, the HELPFUL trial (identifier: NCT04207203), that enrolled 26 adult patients with CKD stages 4 and 5, not on dialysis and with plasma potassium 5.1-6.5 mmol/L at inclusion. In the first 3 weeks, patients were guided to adhere to a low-protein and low-potassium diet with concomitant use of SZC. The following 3 weeks, patients received food baskets containing fruits, vegetables, legumes, nuts, and either white meat, fish or egg to provide a healthy low-protein high-potassium diet. To assess dietary changes, 24-hour food recalls were collected at weeks 0, 3 and 6 and subsequently classified according to the NOVA classification. The mean adequacy ratio to the dietary recommended intake (DRI) of 11 nutrients (MAR-11 score) was calculated to assess dietary quality. Furthermore, the 24-hour food recalls were linked to GHGE estimations for analysis of environmental impact using the RISE food climate database which is representative of Swedish food consumption. Statistical analyses using Friedman's test or ANOVA for repeated measures were employed to identify significant differences before and after the plant-based food basket intervention. This study was funded by Astra Zeneca.

Results
The plasma potassium (mmol/L) normalized after the use of SZC (week 0: 5.52 ± 0.3; week 3: 4.72 ± 0.4; week 6: 4.8 ± 0.4; P &lt; 0.01). Figure 1 shows changes in energy intake according to the NOVA classification. A significant reduction in UPF consumption (P = 0.024) was observed. In the post-hoc analysis, the change between week 3 and 6 was borderline significant (P = 0.052) while that between week 0 and 6 was statistically significant (P = 0.008). The healthy food basket diet led to a significant increase in dietary fibers (P = 0.002) and servings of fruits (P &lt; 0.01), vegetables (P = 0.04), nuts (P &lt; 0.01), poultry (P = 0.02), and fish (P &lt; 0.001) and reduced servings of red meat (P = 0.03). As a result, the MAR-11 score increased significantly (P = 0.021). The GHGE analysis of carbon dioxide equivalents revealed no differences between emissions (median and interquartile range) in week 0 [1.79 (1.24; 3.13)], week 3 [1.79 (1.47; 2.74)] and week 6 [1.87 (1.51; 2.61)].

Conclusion
Delivering medically tailored healthy food baskets to patients with CKD with concomitant use of SZC led to increased dietary quality and decreased UPF intake. However, these beneficial changes were not aligned with a decrease in GHGE, highlighting the complex relationship between dietary choices and environmental impact.