Low Protein Diet in CKD Patients at Risk of Malnutrition
NCT ID: NCT05015647
Last Updated: 2021-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2018-09-26
2020-06-12
Brief Summary
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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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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
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).
PREVENTION
NONE
Study Groups
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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%).
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.
NP group
NP group (n=18) was prescribed high calories/normal proteins diet (30 kcal/kg and 0.8 gr/kg respectively)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Principal Investigators
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Simone Vettoretti, Dr
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy
Locations
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Unit of nephrology, dialysis and renal transplantation - Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico di Milano
Milan, , Italy
Countries
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References
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Other Identifiers
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1274/2018
Identifier Type: -
Identifier Source: org_study_id
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