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Low Protein Diet in CKD Patients at Risk of Malnutrition

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ClinicalTrials.gov Identifier: NCT05015647
Recruitment Status : Completed
First Posted : August 20, 2021
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Malnutrition Dietary Supplement: LP group Other: NP group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants 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).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Is There Any Indication for Protein Free Products in Patients With Advanced CKD at Risk of Malnutrition?A Pilot Randomized Controlled Trial
Actual Study Start Date : September 26, 2018
Actual Primary Completion Date : June 12, 2020
Actual Study Completion Date : June 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LP group
LP group (n=17) was prescribed high calories/low proteins diet (30 Kcal/kg and 0.6-0.7gr/kg respectively) supplemented with commercial protein free products (protein content <2%).
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.

Active Comparator: NP group
NP group (n=18) was prescribed high calories/normal proteins diet (30 kcal/kg and 0.8 gr/kg respectively)
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.




Primary Outcome Measures :
  1. Change from baseline MIS at 6th month [ Time Frame: measured at baseline and 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

  2. Change from baseline serum albumin at 6th month [ Time Frame: measured at baseline and at 6 months. ]
    in g/dL

  3. intergroup MIS comparison at 6 months [ Time Frame: 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

  4. Intergroup comparison of the number of patients that reached a MIS ≥8 at 6 months [ Time Frame: 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


Secondary Outcome Measures :
  1. Differences of GFR estimated with creatinine [ Time Frame: measured at baseline and at 6 months. ]
    In ml/min/1,73m^2

  2. Differences of GFR estimated with cystatin C [ Time Frame: measured at baseline and at 6 months. ]
    in ml/min/1,73m^2

  3. Differences in serum urea [ Time Frame: measured at baseline and at 6 months. ]
    in mg/dl

  4. Differences in creatinine clarance [ Time Frame: measured at baseline and at 6 months. ]
    in ml/min

  5. Differences in phosphorous [ Time Frame: measured at baseline and at 6 months. ]
    in mg/dl

  6. Differences in FGF23 intact [ Time Frame: measured at baseline and at 6 months. ]
    in pg/mL

  7. Differences in FGF23 c-terminal [ Time Frame: measured at baseline and at 6 months. ]
    in RU/mL

  8. Differences in urinary phosphorous [ Time Frame: measured at baseline and at 6 months. ]
    in mg/24h

  9. Differences in PTH [ Time Frame: measured at baseline and at 6 months. ]
    in ng/L

  10. Differences in bicarbonate [ Time Frame: measured at baseline and at 6 months. ]
    in mEq/L

  11. Differences in pH [ Time Frame: measured at baseline and at 6 months. ]
    pH

  12. Differences in CRP [ Time Frame: measured at baseline and at 6 months. ]
    in mg/dl

  13. Differences in IL6 [ Time Frame: measured at baseline and at 6 months. ]
    in pg/mL

  14. Differences in the short physical performance battery scores [ Time Frame: at months 1 and 6 ]
    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

  15. Differences of the handgrip strength [ Time Frame: measured at baseline and at 6 months. ]
    in Kg. Handgrip strength was measured with Jamar dynamometer and was considered to be impaired for values <16kg in females and <27kg in males

  16. Differences in the body composition (lean body mass, fat body mass, water) in the two study groups (bio impedance) [ Time Frame: measured at baseline and at 6 months. ]
    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).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05015647


Locations
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Italy
Unit of nephrology, dialysis and renal transplantation - Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico di Milano
Milan, Italy, 20122
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
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Principal Investigator: Simone Vettoretti, Dr Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy
Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT05015647    
Other Study ID Numbers: 1274/2018
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: since it is a collaborative study, the data may be made available to other researchers only following a specific and motivated request that must be approved by all members of the consortium

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
chronic kidney disease
Malnutrition
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Malnutrition
Urologic Diseases
Renal Insufficiency
Nutrition Disorders