Abstract

Abstract BACKGROUND AND AIMS Healthy plant-based diets (HealthyPB diet) may offer metabolic and cardiovascular benefits to patients with CKD. However, the higher potassium (K+) content of these diets is a concern when prescribed to CKD patients with hyperkalemia (HK). Potassium-lowering medication, such as SZC, can be a treatment option to allow better control of plasma K + for those ingesting a HealthyPB diet. We investigated whether patients with CKD stage 4–5 and HK can be safely prescribed a HealthyPB diet with increased K + content by concomitant use of SZC. METHOD This is an ongoing open label feasibility clinical trial that will include 36 patients with CKD stage 4–5 not on dialysis with HK (plasma K+ ≥ 5.1 mmol/L). Patients with plasma K+ > 6.5 mmol/L are excluded. Intervention: Patients are followed for 6 weeks. In the first 3 weeks (stabilization phase), SZC is prescribed according to the drug label to normalize plasma K + while ingesting a low protein diet (0.6–0.8 g/kg/day) with low content of K+ (2.3 g/day) as counselled by a dietitian. After 3 weeks, patients initiate and follow for 3 additional weeks, the HealthyPB diet containing unchanged low amount of protein and K + content of 3.7–4 g/day. In order to increase diet adherence, a food basket (containing fruits, vegetables, whole grains, nuts, whole cereals, white meat, fish or eggs in amounts adequate for the patient and the family) is delivered to patient's home once per week. Serum K is closely monitored and the dose of SZC is adjusted according to the drug label to maintain serum K between 3.5 and 5.0 mmol/L. Adherence to the diet is assessed by 24-h urinary K + excretion, 24-h food record, and a semi-quantitative short food questionnaire at the beginning and end of the stabilization phase and again at the beginning and end of the HealthyPB diet phase. The protocol is registered at www.clinicaltrials.gov (identifier NCT04207203). RESULTS Among 14 patients included so far, 12 completed the study protocol and 2 are being followed. Results in the patients (n = 12; age 56.5 ± 10 years; 66.7% men; eGFR: 16.4 ± 4.6 mL/min/1.73 m2) who completed the follow-up are described in the Table 1. Mean ± SD or median and interquartile range; NA: not assessed. At the end of follow-up three (25%) patients had plasma K + between 5.1 and 5.3 mmol/L. CONCLUSION These preliminary results indicate that patients adhered to the low protein HealthyPB diet with an increase in the intake of fruits, vegetables, whole cereals and nuts. The mean plasma K + was well controlled with SZC and within the normal range after the start of the HealthyPB diet.

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