AzTrials
AzTrials

Chronic Kidney DiseasesNCT05015647

Low Protein Diet in CKD Patients at Risk of Malnutrition

A study testing LP group and NP group in people with Chronic Kidney Diseases and Malnutrition, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Chronic Kidney Diseases, Malnutrition
What is being tested?
LP group and NP group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteItaly
Study dates
26 Sep 2018to 12 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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).

Who cannot join

  • Active chronic infectious diseases
  • Heart failure of severity > NYHA2
  • Active neoplastic diseases
  • Inability to cooperate
  • Presumed overall life expectancy < 6 month
  • Decompensated liver diseases
Show all 10Show fewer
  • Malabsorption
  • Decompensated thyroid o surrenal diseases
  • Refusal to participate
  • Immunosuppressive and/or steroid therapy

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Milan, 20122

Other trials in Italy

About this study

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

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:

Read more
  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.

Read the 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.

Being tested
LP group, NP group
Keywords
chronic kidney disease, Malnutrition
Medical subject headings
Renal Insufficiency, Chronic, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LP groupDietary 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 groupOther

    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.

Study groups in NCT05015647
Study groupRoleWhat they receive
LP groupExperimentalLP 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%).
Receives: Dietary Supplement: LP group
NP groupActive comparatorNP group (n=18) was prescribed high calories/normal proteins diet (30 kcal/kg and 0.8 gr/kg respectively)
Receives: Other: NP group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: measured at baseline and 6 months.

  2. Change from baseline serum albumin at 6th month

    in g/dL

    Measured: measured at baseline and at 6 months.

  3. 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

    Measured: 6th month

  4. 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

    Measured: 6th month

Secondary outcomes (16)

  1. Differences of GFR estimated with creatinine

    In ml/min/1,73m^2

    Measured: measured at baseline and at 6 months.

  2. Differences of GFR estimated with cystatin C

    in ml/min/1,73m^2

    Measured: measured at baseline and at 6 months.

  3. Differences in serum urea

    in mg/dl

    Measured: measured at baseline and at 6 months.

  4. Differences in creatinine clarance

    in ml/min

    Measured: measured at baseline and at 6 months.

  5. Differences in phosphorous

    in mg/dl

    Measured: measured at baseline and at 6 months.

  6. Differences in FGF23 intact

    in pg/mL

    Measured: measured at baseline and at 6 months.

  7. Differences in FGF23 c-terminal

    in RU/mL

    Measured: measured at baseline and at 6 months.

  8. Differences in urinary phosphorous

    in mg/24h

    Measured: measured at baseline and at 6 months.

  9. Differences in PTH

    in ng/L

    Measured: measured at baseline and at 6 months.

  10. Differences in bicarbonate

    in mEq/L

    Measured: measured at baseline and at 6 months.

  11. Differences in pH

    pH

    Measured: measured at baseline and at 6 months.

  12. Differences in CRP

    in mg/dl

    Measured: measured at baseline and at 6 months.

  13. Differences in IL6

    in pg/mL

    Measured: measured at baseline and at 6 months.

  14. 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

    Measured: at months 1 and 6

  15. 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: measured at baseline and at 6 months.

  16. 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: measured at baseline and at 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2021
  2. Study start26 Sep 2018
  3. Primary completion12 Jun 2020
  4. Study completion12 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05015647
Sponsor's protocol ID
1274/2018
Status last verified
Aug 2021
First submitted
11 Aug 2021
Last updated
20 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • Ikizler TA, Greene JH, Wingard RL, Parker RA, Hakim RM. Spontaneous dietary protein intake during progression of chronic renal failure. J Am Soc Nephrol. 1995 Nov;6(5):1386-91. doi: 10.1681/ASN.V651386.

    PubMed 8589313

  • Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. doi: 10.1172/JCI16494. No abstract available.

    PubMed 12189236

  • Mitch WE. Cachexia in chronic kidney disease: a link to defective central nervous system control of appetite. J Clin Invest. 2005 Jun;115(6):1476-8. doi: 10.1172/JCI25255.

    PubMed 15931387

  • Tom K, Young VR, Chapman T, Masud T, Akpele L, Maroni BJ. Long-term adaptive responses to dietary protein restriction in chronic renal failure. Am J Physiol. 1995 Apr;268(4 Pt 1):E668-77. doi: 10.1152/ajpendo.1995.268.4.E668.

    PubMed 7733266

  • Masud T, Young VR, Chapman T, Maroni BJ. Adaptive responses to very low protein diets: the first comparison of ketoacids to essential amino acids. Kidney Int. 1994 Apr;45(4):1182-92. doi: 10.1038/ki.1994.157.

    PubMed 8007590

  • Goodship TH, Mitch WE, Hoerr RA, Wagner DA, Steinman TI, Young VR. Adaptation to low-protein diets in renal failure: leucine turnover and nitrogen balance. J Am Soc Nephrol. 1990 Jul;1(1):66-75. doi: 10.1681/ASN.V1166.

    PubMed 2104252

  • Kopple JD, Monteon FJ, Shaib JK. Effect of energy intake on nitrogen metabolism in nondialyzed patients with chronic renal failure. Kidney Int. 1986 Mar;29(3):734-42. doi: 10.1038/ki.1986.59.

    PubMed 3702224

  • Garibotto G, Sofia A, Parodi EL, Ansaldo F, Bonanni A, Picciotto D, Signori A, Vettore M, Tessari P, Verzola D. Effects of Low-Protein, and Supplemented Very Low-Protein Diets, on Muscle Protein Turnover in Patients With CKD. Kidney Int Rep. 2018 Jan 11;3(3):701-710. doi: 10.1016/j.ekir.2018.01.003. eCollection 2018 May.

    PubMed 29854979

  • Ikizler TA, Burrowes JD, Byham-Gray LD, Campbell KL, Carrero JJ, Chan W, Fouque D, Friedman AN, Ghaddar S, Goldstein-Fuchs DJ, Kaysen GA, Kopple JD, Teta D, Yee-Moon Wang A, Cuppari L. KDOQI Clinical Practice Guideline for Nutrition in CKD: 2020 Update. Am J Kidney Dis. 2020 Sep;76(3 Suppl 1):S1-S107. doi: 10.1053/j.ajkd.2020.05.006.

    PubMed 32829751

  • Farrington K, Covic A, Aucella F, Clyne N, de Vos L, Findlay A, Fouque D, Grodzicki T, Iyasere O, Jager KJ, Joosten H, Macias JF, Mooney A, Nitsch D, Stryckers M, Taal M, Tattersall J, Van Asselt D, Van den Noortgate N, Nistor I, Van Biesen W; ERBP guideline development group. Clinical Practice Guideline on management of older patients with chronic kidney disease stage 3b or higher (eGFR <45 mL/min/1.73 m2). Nephrol Dial Transplant. 2016 Nov;31(suppl 2):ii1-ii66. doi: 10.1093/ndt/gfw356. No abstract available.

    PubMed 27807144

  • Rhee CM, Ahmadi SF, Kovesdy CP, Kalantar-Zadeh K. Low-protein diet for conservative management of chronic kidney disease: a systematic review and meta-analysis of controlled trials. J Cachexia Sarcopenia Muscle. 2018 Apr;9(2):235-245. doi: 10.1002/jcsm.12264. Epub 2017 Nov 2.

    PubMed 29094800

  • Fouque D, Kalantar-Zadeh K, Kopple J, Cano N, Chauveau P, Cuppari L, Franch H, Guarnieri G, Ikizler TA, Kaysen G, Lindholm B, Massy Z, Mitch W, Pineda E, Stenvinkel P, Trevino-Becerra A, Wanner C. A proposed nomenclature and diagnostic criteria for protein-energy wasting in acute and chronic kidney disease. Kidney Int. 2008 Feb;73(4):391-8. doi: 10.1038/sj.ki.5002585. Epub 2007 Dec 19.

    PubMed 18094682

  • Cupisti A, Brunori G, Di Iorio BR, D'Alessandro C, Pasticci F, Cosola C, Bellizzi V, Bolasco P, Capitanini A, Fantuzzi AL, Gennari A, Piccoli GB, Quintaliani G, Salomone M, Sandrini M, Santoro D, Babini P, Fiaccadori E, Gambaro G, Garibotto G, Gregorini M, Mandreoli M, Minutolo R, Cancarini G, Conte G, Locatelli F, Gesualdo L. Nutritional treatment of advanced CKD: twenty consensus statements. J Nephrol. 2018 Aug;31(4):457-473. doi: 10.1007/s40620-018-0497-z. Epub 2018 May 24.

    PubMed 29797247

  • Hanna RM, Ghobry L, Wassef O, Rhee CM, Kalantar-Zadeh K. A Practical Approach to Nutrition, Protein-Energy Wasting, Sarcopenia, and Cachexia in Patients with Chronic Kidney Disease. Blood Purif. 2020;49(1-2):202-211. doi: 10.1159/000504240. Epub 2019 Dec 18.

    PubMed 31851983

  • Deer RR, Volpi E. Protein Requirements in Critically Ill Older Adults. Nutrients. 2018 Mar 20;10(3):378. doi: 10.3390/nu10030378.

    PubMed 29558388

Questions about this trial

What is this clinical trial studying?

A study testing LP group and NP group in people with Chronic Kidney Diseases and Malnutrition, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline MIS at 6th month (time frame: measured at baseline and 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05015647, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in