NCT05015647

Low Protein Diet in CKD Patients at Risk of Malnutrition

Is There Any Indication for Protein Free Products in Patients With Advanced CKD at Risk of Malnutrition?A Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

It's a pilot study with an open label randomized-controlled design. Estimated number of patients should have been 38, taking in account of a maximal drop out up to 20% of the sample. We enrolled 35 patients, 27 of whom terminated the study as per protocol (14 in the Low protein (LP) group and 13 in the Normo Protein (NP) group). Patients were treated for six months with two different dietary prescriptions: 1. LP group (n=17) was prescribed high calories/low proteins diet (30 Kcal/kg and 0.6-0.7gr/kg respectively). In order to assure prescribed calorie intake, this group was supplemented with commercial protein free products (protein content \<2%). 2. NP group (n=18) was prescribed high calories/normal proteins diet (30 kcal/kg and 0.8 gr/kg respectively). The primary hypothesis of the study was that in CKD patients at risk of malnutrition (4 ≤ MIS ≥7) with a persistent spontaneous low protein and calories intake, the prescription of a LP diet was not inferior to NP diet regarding the development of malnutrition (i.e.MIS ≥ 8). We also wanted to test whether in these patients, the prescription of a LP diet was superior to the NP comparator regarding the control of the metabolic complication of chronic kidney diseases (i.e hyperphosphatemia, inflammation and metabolic acidosis), the progression on dyna/sarcopenia, inflammation and possibly on the progression of renal disease itself.

Detailed description

Nutritional status will be evaluated through: * Malnutrition Inflammation Score (MIS), * Anthropometric measurements, * albumin, prealbumin, transferrin, * 24h urinary nitrogen, * bioimpedance analysis (BIA), * periodic 24h dietary diaries, * International Society of Renal Nutrition and Metabolism (ISRNM), Physical performance will be evaluated through: * Short Physical Performance Battery (SPPB) * Handgrip strength Inflammation assessment: * c-reactive protein (CRP) * Interleukine-6 (IL6) * whole blood Neutrophil/lymphocyte ratio Renal function assessment: * eGFR based on serum creatinine and cystatin C * average creatinine and urea clearance Uremic metabolic alteration: * serum urea * serum phosphate * serum FGF23 * parathormone (PTH), * plasma pH and bicarbonate Time points of evaluation Dietary compliance has been assessed by a trained nutritionist at months 1, 2, 3 and 6. Dietary consumption was estimated by using dietary diaries and normalized catabolic protein rate (nPCR) measurement at baseline, 3 and at 6 months. Nutritional status and physical performance have been evaluated monthly for the first three months and then at 6 months.

Conditions

• Chronic Kidney Diseases
• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	LP group	LP group patients replaced pasta, bread, biscuits etc. with low protein substitutes. We allowed them to consume more animal products than NP, preferring white meat to red meat and trying to limit cold cuts as much as possible. Furthermore, they were advised to prefer fresh or frozen fish, instead of dried or smoked one as well as to prefer fresh cheeses to seasoned ones. As for legumes, we advised to combine them with bread or normal cereals, for protein complementarity.
OTHER	NP group	NP group was given the indication to try to eat the second dish only once a day or to split the portion of the second plate between lunch and dinner, if they wanted to keep the habit of making the meal complete. It was also given the indication to prefer, among protein sources, those of plant origin. We also indicated to alternate or replace cow's milk with plant substitutes such as: rice, almonds' or oats' drinks. Furthermore, we suggested to prefer white meat and to avoid offal and processed meat. Moreover, we indicated to substitute dried or smoked fish with fresh or frozen one.

Timeline

• Start date: 2018-09-26
• Primary completion: 2020-06-12
• Completion: 2020-06-12
• First posted: 2021-08-20
• Last updated: 2021-08-20

Locations

1 site across 1 country: Italy