Low-protein diet: summary of product characteristics

Authors

  • Andreana De Mauri SSvD Nefrologia e Dialisi, Ospedale Maggiore della Carità, Novara - Italy https://orcid.org/0000-0002-3266-195X
  • Deborah Carrera SC Scienze dell’Alimentazione e Dietetica, Ospedale Maggiore della Carità, Novara - Italy https://orcid.org/0000-0002-7247-9650
  • Elena Capello SC Scienze dell’Alimentazione e Dietetica, Ospedale Maggiore della Carità, Novara - Italy
  • Sergio Riso SC Scienze dell’Alimentazione e Dietetica, Ospedale Maggiore della Carità, Novara - Italy https://orcid.org/0000-0001-8798-1224
  • Doriana Chiarinotti SSvD Nefrologia e Dialisi, Ospedale Maggiore della Carità, Novara - Italy https://orcid.org/0000-0003-1817-5821
  • Claudia D'Alessandro Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa, Nefrologia Trapianto e Dialisi, Pisa - Italy https://orcid.org/0000-0003-2313-5461

DOI:

https://doi.org/10.33393/gcnd.2022.2493

Keywords:

Drug, Low-protein diet, Summary of Product Characteristics

Abstract

National and International Societies recommend the Low Protein Diet (LPD) as nutritional therapy for chronic kidney disease not on dialysis, because it reduces the uremic symptoms and toxins generation, preserves the nutritional status, delays the progression to the dialysis and reshapes the dysbiotic microbiota. Finally, LPD is low cost and eco- and planet friendly.  As some Authors already described LPD as a traditional drug, with particular indications, contraindications, special populations and so on, we for the first time re-wrote the LPD characteristics according to the “Summary of Product Characteristics” required by the Italian Health Department and Italian Medicines Agency.  However, the contents of this paper could not be “literally” applied by clinicians, but must be included in a global assessment of the patient and performed by a trained physician or dietitian with expertise in the management of chronic kidney disease. 

Downloads

Download data is not yet available.

References

Cupisti A, Bolasco P, D’Alessandro C, Giannese D, Sabatino A, Fiaccadori E. Protection of residual renal function and nutritional treatment: first step strategy for reduction of uremic toxins in end stage renal disease. Toxins (Basel). 2021;13(4):289-298. https://doi.org/10.3390/toxins13040289 PMID:33921862 DOI: https://doi.org/10.3390/toxins13040289

Camerotto C, Cupisti A, D’Alessandro C, Muzio F, Gallieni M. Dietary fiber and gut microbiota in renal diets. Nutrients. 2019;11(9):2149-2163. https://doi.org/10.3390/nu11092149PMID:31505733 DOI: https://doi.org/10.3390/nu11092149

Piccoli GB, Nazha Mm Capizzi I, et al. Patient survival and costs on moderately restricted low-protein diet in advanced CKD: equivalent survival at lower costs? Nutrients. 2016;8(12):758769. https://doi.org/10.3390/nu8120758 PMID: 27898000 DOI: https://doi.org/10.3390/nu8120758

Piccoli GB, Cupisti A, Aucella F, et al; On the Behalf of Conservative treatment, Physical activity and Peritoneal dialysis project groups of the Italian Society of Nephrology. Green nephrology and eco-dialysis: a position statement by the Italian Society of Nephrology. J Nephrol. 2020;33(4):681-698. https://doi.org/10.1007/s40620-020-00734-z PMID:32297293 DOI: https://doi.org/10.1007/s40620-020-00734-z

Cupisti A, Brunori G, Di Iorio BR, et al. Nutritional treatment of advanced CKD: twenty consensus statements. J Nephrol. 2018;31(4):457-473. https://doi.org/10.1007/s40620-018-0497-zPMID:29797247 DOI: https://doi.org/10.1007/s40620-018-0497-z

Ikizler TA, Burrowes JD, Bhyam-Gray LD, et al. KDOQI Clinical practice guideline for nutrition in CKD: 2020 update. Am J Kidenay disease 2020: 76 (S3): 1-107. https://doi.org/10.1053/j.ajkd.2020.05.006 PMID: 32829751 DOI: https://doi.org/10.1016/B978-0-12-818540-7.00018-5

Cupisti A, Gallieni M, Avesani CM, D’Alessandro C, Carrero JJ, Piccoli GB. Medical nutrition therapy for patients with chronic kidney disease not on dialysis: the low protein diet as a medication. J Clin Med. 2020;9(11):3644-3663. https://doi.org/10.3390/jcm9113644PMID:33198365 DOI: https://doi.org/10.3390/jcm9113644

AIFA. La Banca Dati Farmaci. Online https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/ (Accessed July 2022)

AIFA. Riassunto delle Caratteristiche del Prodotto e Foglio Illustrativo. Online https://www.aifa.gov.it/riassunto-caratteristiche-e-foglio-illustrativo (Accessed July 2022)

Regolamento (Ue) N. 609/2013 del Parlamento Europeo e del Consiglio del 12 Giugno 2013. Online https://eur-lex.europa.eu/legal-content/IT/TXT/PDF/?uri=CELEX:32013R0609&from=IT (Accessed July 2022

Regolamento delegato (UE) 2016/128 della Commissione, del 25 settembre 2015 https://eur-lex.europa.eu/legal-content/it/ALL/?uri=CELEX:32016R0128 (Accessed July 2022)

KDOQI Work Group. 2008 Update. Executive summary. Am J Kidney Dis. 2009;53(3)(suppl 2):S11-S104. https://doi.org/10.1053/j.ajkd.2008.11.017 PMID:19231749 DOI: https://doi.org/10.1053/j.ajkd.2008.11.017

Shaw V, Polderman N, Renken-Terhaerdt J, et al. Energy and protein requirements for children with CKD stages 2-5 and on dialysis-clinical practice recommendations from the Pediatric Renal Nutrition Taskforce. Pediatr Nephrol. 2020;35(3):519-531. https://doi.org/10.1007/s00467-019-04426-0 PMID:31845057 DOI: https://doi.org/10.1007/s00467-019-04426-0

D’Alessandro C, Benedetti A, Di Paolo A, Giannese D, Cupisti A. Interactions between food and drugs, and nutritional status in renal patients: a narrative review. Nutrients. 2022;14(1):212-236. https://doi.org/10.3390/nu14010212 PMID:35011087 DOI: https://doi.org/10.3390/nu14010212

Published

2022-11-22

How to Cite

De Mauri, A., Carrera, D., Capello, E., Riso, S., Chiarinotti, D., & D’Alessandro, C. (2022). Low-protein diet: summary of product characteristics. Giornale Di Clinica Nefrologica E Dialisi, 34(1), 99–104. https://doi.org/10.33393/gcnd.2022.2493

Issue

Section

Original articles

Categories

Received 2022-09-15
Accepted 2022-11-09
Published 2022-11-22

Metrics