#2408 Effect of low and very low protein diet with ketoanalogue on progression of CKD, quality of life and KAP in India: an interim analysis
Authors: Mahapatra Himansu , Khattar Deepshikha , Lakshman Lakshman , B Muthukumar 
Published: May 2024

Abstract

Background and Aims
Recent studies have established lack of advantages of Very Low Protein (VLP) with Ketoanalogues in CKD progression against to the KIDGO guidelines [1]. No systematic study is available in India to examine effect of Low protein (LP) and VLP with Ketoanalogue towards CKD prevention even though there were diverse in dietary habits. Further, effect of counseling on QoL, KAP and CKD outcomes have also not been examined. Present study intended to examine effect of dietary intervention on CKD progression, QoL, and KAP.

Method
This ongoing prospective randomized controlled trial was initiated since December 2022. A total of 198 patients of CKD 3 to 5 (ND) of age 18 to 60 years were completed one year. Enrolled subjects were screened from Nephrology OPD for CKD diagnosis and counselling was done for dietary intake. Their basic demographic profile socio- economic status, dietary habits, physical activity and biochemical details are being recorded through which e-GFR is calculated by CKD-EPI formula at baseline. All were randomised into 3 groups- Normal protein (0.8-1.0 gm/kg/day), low protein (0.6 gm/kg/day) and very low protein supplemented with Ketoanalogues (0.3 gm/kg/day) as a method of dietary intervention. Their dietary nutrient analysis (calories, protein, sodium, potassium, and phosphorus) was done by Diet Cal version 10.0 software using a 4-day dietary record. Dietary nutrients, nutritional status (BMI, BP, pallor, MUAC and handgrip) and all other parameters were measured at baseline, at 6th and 12th month. All patients underwent dietary intervention with home-based Personalised supervision (PS) diet. Dietary re-enforcement and counselling for clinical as well as diet-related patient concerns were done by exclusive renal dietician with weekly telephone calls. KAP and QoL were also recorded at baseline and after 6 months. The parameters were analysed by using the paired t-tests and one-way ANOVA to assess Effect of PS.

Results
A total 198 subjects were completed one year study. The detail demography has depicted in Table 1. Among them 79% were literate and 58.6%, 34.5%, and 6.8% were Non vegetarian, vegetarians and ovo-vegetarian respectively. Of total, there were CKD 3 (NP-30, LP- 28 and VLP-33), CKD 4 (LP-31 and VLP-32) and CKD 5 (LP-16 and VLP- 27) respectively. At baseline, all three stages have low protein intake (CKD3-36.0 g, CKD 4-34.1 g and CKD 5-31.6 g) against the standard (36.6-43.3 g) in 61 kg as mean weight. Further, in normal, low and very low groups there were 36.1 g, 35.5 g and 31.0 g protein intake respectively. Intake of sodium was high and potassium was low, which has been reversed after 1 year. (p = .000). Further, there were significant improvement in most of nutritional and biochemical parameters. However, total dietary intake and calories increased but couldn't reach to the recommendations in non-dialysis patients. (Table 1) As shown in Fig. 1, the e-GFR has increases in all groups, whereas in VLP group it has decreases non- significantly at one year. Physical component score (PCS) as QoL has improved from 2389.1 ± 415.2 to 3527.2 ± 657.5 (p = .000) whereas, Mental component score (MCS) has decreased. After counselling, all the components of KAP have been improved significantly.

Conclusion
Interim analysis showed that at sixth month there was slowing in progression of CKD manifested by increase in e-GFR among NP, LP and VLP with Ketoanalogue group, whereas at one year, there were non- significant reduction in VLP group. After dietary counselling, both KAP and PCS have been improved significantly.