Balancing protein intake: A randomized control trial of low,very low with alpha-ketoanalogue,and normal protein diets impact on quality of life in non-dialysis chronic kidney disease patients

Abstract

Background

Chronic kidney disease (CKD) significantly impacts physical and mental well-being, and dietary interventions such as low protein diet (LPD) and very low protein diet (VLPD) with ketoanalogue essential amino acids (KAEAAs) may improve quality of life (QoL) and slow disease progression.

Aims

To evaluate the effects of LPD and VLPD with KAEAA on QoL in pre-dialysis CKD patients (stages 3–5).

Methodology

A randomized, open-label study was conducted from 2022 to 2023 November at tertiary care centre, enrolling 199 patients with CKD3 to CKD5 (not on dialysis). Participants were allocated to normal protein (NP), LPD, or VLPD + KAEAA groups in stage 3, and LPD or VLPD + KAEAA groups in stages 4 and 5. QoL was assessed at baseline and after 1 year using the KDQOL-SF-36™ v1.3 survey, evaluating physical component score (PCS), mental component score (MCS), and domain-specific changes.

Results

Among 199 pre-dialysis CKD patients, stage 3 participants showed significant decline in physical functioning with both LPD (p = 0.00) and VLPD (p = 0.02), while emotional well-being improved slightly. PCS declined across all groups, but MCS improved marginally with VLPD and declined in LPD and NP. In stage 4, both LPD and VLPD diets led to reductions in PCS and MCS. Cognitive function improved significantly with LPD (p = 0.03). In stage 5, VLPD patients showed marked improvements in pain (p = 0.00), kidney disease burden (p = 0.05), physical function, sleep, sexual function, and social support, while LPD offered only modest gains.

Conclusion

VLPD with ketoanalogues offers superior QoL benefits, particularly in advanced CKD, compared to LPD.