Low Protein Diet in CKD Patients at Risk of Malnutrition

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05015647
• Other study ID #: 1274/2018
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: June 12, 2020

Study information

• Verified date: August 2021
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• advanced CKD not yet on renal replacement therapy (10< - eGFRcreat <30 ml/min)

• age >65 years

• at risk of malnutrition at Malnutrition Inflammation Score (4=MIS=7)

• spontaneous low protein-energy intake (proteins < 0.8g/kg and energy < 25 kcal/kg).

Exclusion Criteria:

• Active chronic infectious diseases

• Heart failure of severity > NYHA2

• Active neoplastic diseases

• Inability to cooperate

• Presumed overall life expectancy < 6 month

• Decompensated liver diseases

• Malabsorption

• Decompensated thyroid o surrenal diseases

• Refusal to participate

• Immunosuppressive and/or steroid therapy

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Malnutrition
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Italy	Unit of nephrology, dialysis and renal transplantation - Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico di Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline MIS at 6th month	Malnutrition-inflammation score is a validated scoring system for the assessment of malnutrition and inflammation syndrome in patients with CKD. MIS involves the evaluation of ten different domains, each of which is categorized with 4 severity levels (score scale 0-3). A total score of 4-7 was considered indicative of mild malnutrition and a score =8 of severe malnourishment	measured at baseline and 6 months.
Primary	Change from baseline serum albumin at 6th month	in g/dL	measured at baseline and at 6 months.
Primary	intergroup MIS comparison at 6 months	Malnutrition-inflammation score is a validated scoring system for the assessment of malnutrition and inflammation syndrome in patients with CKD. MIS involves the evaluation of ten different domains, each of which is categorized with 4 severity levels (score scale 0-3). A total score of 4-7 was considered indicative of mild malnutrition and a score =8 of severe malnourishment	6th month
Primary	Intergroup comparison of the number of patients that reached a MIS =8 at 6 months	Malnutrition-inflammation score is a validated scoring system for the assessment of malnutrition and inflammation syndrome in patients with CKD. MIS involves the evaluation of ten different domains, each of which is categorized with 4 severity levels (score scale 0-3). A total score of 4-7 was considered indicative of mild malnutrition and a score =8 of severe malnourishment	6th month
Secondary	Differences of GFR estimated with creatinine	In ml/min/1,73m^2	measured at baseline and at 6 months.
Secondary	Differences of GFR estimated with cystatin C	in ml/min/1,73m^2	measured at baseline and at 6 months.
Secondary	Differences in serum urea	in mg/dl	measured at baseline and at 6 months.
Secondary	Differences in creatinine clarance	in ml/min	measured at baseline and at 6 months.
Secondary	Differences in phosphorous	in mg/dl	measured at baseline and at 6 months.
Secondary	Differences in FGF23 intact	in pg/mL	measured at baseline and at 6 months.
Secondary	Differences in FGF23 c-terminal	in RU/mL	measured at baseline and at 6 months.
Secondary	Differences in urinary phosphorous	in mg/24h	measured at baseline and at 6 months.
Secondary	Differences in PTH	in ng/L	measured at baseline and at 6 months.
Secondary	Differences in bicarbonate	in mEq/L	measured at baseline and at 6 months.
Secondary	Differences in pH	pH	measured at baseline and at 6 months.
Secondary	Differences in CRP	in mg/dl	measured at baseline and at 6 months.
Secondary	Differences in IL6	in pg/mL	measured at baseline and at 6 months.
Secondary	Differences in the short physical performance battery scores	SPPB includes: test of standing balance, 4-meter walk and time to rise from a chair five times. Each SPPB component test is scored from 0 to 4. Higher scores indicate better physical performance	at months 1 and 6
Secondary	Differences of the handgrip strength	in Kg. Handgrip strength was measured with Jamar dynamometer and was considered to be impaired for values <16kg in females and <27kg in males	measured at baseline and at 6 months.
Secondary	Differences in the body composition (lean body mass, fat body mass, water) in the two study groups (bio impedance)	water in L, Lean body mass in Kg/m2 and fat body mass in Kg/m2. Body composition was measured by using a multifrequency bioelectrical impedance analysis device (BCM- Body Composition Monitor, Fresenius Medical Care, Bad Homburg, Germany).	measured at baseline and at 6 months.