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Completed

NCT Number: NCT05015647

Low Protein Diet in CKD Patients at Risk of Malnutrition

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit of nephrology, dialysis and renal transplantation - Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LP group

Dietary Supplement

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.

NP group

Other

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 20, 2021
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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