Is There Any Indication for Protein Free Products in Patients With Advanced CKD at Risk of Malnutrition?A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Change from baseline serum albumin at 6th month
Study Overview
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:
- 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%).
- 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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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%).
Intervention: LP group (Dietary Supplement)
NP group
NP group (n=18) was prescribed high calories/normal proteins diet (30 kcal/kg and 0.8 gr/kg respectively)
Intervention: NP group (Other)
Outcomes
Primary Outcomes
Change from baseline serum albumin at 6th month
Time Frame: measured at baseline and at 6 months.
in g/dL
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
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
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
- Differences of GFR estimated with creatinine(measured at baseline and at 6 months.)
- Differences in PTH(measured at baseline and at 6 months.)
- Differences in phosphorous(measured at baseline and at 6 months.)
- Differences in FGF23 c-terminal(measured at baseline and at 6 months.)
- Differences in bicarbonate(measured at baseline and at 6 months.)
- Differences in CRP(measured at baseline and at 6 months.)
- Differences of GFR estimated with cystatin C(measured at baseline and at 6 months.)
- Differences in FGF23 intact(measured at baseline and at 6 months.)
- Differences in pH(measured at baseline and at 6 months.)
- Differences of the handgrip strength(measured at baseline and at 6 months.)
- Differences in serum urea(measured at baseline and at 6 months.)
- Differences in creatinine clarance(measured at baseline and at 6 months.)
- Differences in the body composition (lean body mass, fat body mass, water) in the two study groups (bio impedance)(measured at baseline and at 6 months.)
- Differences in urinary phosphorous(measured at baseline and at 6 months.)
- Differences in IL6(measured at baseline and at 6 months.)
- Differences in the short physical performance battery scores(at months 1 and 6)