#4456 HEALTHY PLANT-BASED DIET IN CHRONIC KIDNEY DISEASE THROUGH USE OF SODIUM ZIRCONIUM CYCLOSILICATE (HELPFUL TRIAL): RESULTS OF DIETARY INTAKE

Abstract

Abstract Background and Aims The dietary restriction of healthy food sources of potassium (K) counselled to patients with chronic kidney disease (CKD) and hyperkalemia (HK) contributes to a diet with poor dietary quality. The K lowering medication sodium zirconium cyclosilicate (SZC) has the potential to treat HK, thereby allowing a healthy plant-based diet (PBD). We designed a clinical trial to explore the safety and feasibility of prescribing a healthy PBD to CKD patients with HK with the concomitant use of SZC. Method The HELPFUL trial is an ongoing single-arm study with CKD stage 4-5 patients not on dialysis and with plasma K (pK) between 5.1-6.5 mmol/L at inclusion. Patients are followed for six weeks. In the first three weeks, SZC is prescribed to normalize pK while patients ingest a low protein diet with low K content. In the subsequent three weeks, a healthy PBD with a target K intake of 3700 mg/day is prescribed while maintaining the use of SZC. A food basket with PBD is delivered to participants weekly. A weekly monitoring of pK and titration of SZC to keep normokalemia is performed. Two dietary quality scores were calculated using the 24-hour food record (24h-FR) at baseline, week three and six. The first index is the Swedish version of Nutrient rich food index (S-NRF11.3) that measures the density of 11 beneficial nutrients (fiber, folate, iron, calcium, potassium, protein and vitamins A, C, D and E) and three non-beneficial nutrients (saturated fat, sodium and added sugars). The second index is the mean adequacy ratio (MAR) with the average intake of the same 11 beneficial nutrients as a proportion of the recommended daily intake (RDI). Data was analyzed by repeated measures-ANOVA or by Friedman test for related samples, as appropriate. Registered at www.clinicaltrials.gov (identifier NCT04207203). Results 22 patients were included; 59±13 years; 13 men, eGFR 18±4 mL/min/1,73m2 (Table 1). The total intake of energy, fibre, folate and K increased significantly in week 6. Nutrient density did not change, but the MAR-score increased significantly. The intake of servings of fruits, vegetables and nuts increased significantly throughout the PBD. Regarding animal protein, there was a tendency to decrease the intake of servings of red meat and a significant increase in poultry and fish. The mean pK normalized in week three and six. After the start of PBD, three patients (13.6%) had pK between 5.1-5.3 mmol/L. Conclusion The strategy of PBD food baskets with concomitant use of SZC improved the dietary quality and increased the intake of servings of healthy foods. The K intake increased but not to target value. The pK was kept within normal values for most patients.