federico II university, department of nephrology
Naples, 80129, Italy
NCT Number: NCT01865526
The dietary restriction of proteins and sodium is a cornerstone in the treatment of chronic kidney disease (CKD) and of its metabolic consequences. Dietary adjustments in CKD are complex and the patients' compliance is very low. A dietary interview method is a validated instrument to evaluate the patients' compliance; however, it the presence of a dedicated dietitians. For these reasons, and because of the absence of dedicated dietitians in many nephrology centres, it is usual practice to give standard low protein diets to CKD patients not on dialysis.
Aim of this study was to verify if few simple tips were able to reduce protein, phosphate and sodium intake in patients with CKD, as compared to the practice of giving a low protein diet elaborated by a renal dietitian.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Naples, 80129, Italy
The dietary restriction of proteins and sodium is a cornerstone in the treatment of chronic kidney disease (CKD) and of its metabolic consequences. In fact, a reduced protein intake decreases load on remaining nephrons, reduces signs and symptoms of uraemia, lessens the accumulation of waste metabolic products and oxidant stress, improves insulin-resistance and lipid profile, ameliorates proteinuria, additives effects of angiotensin-converting-enzyme inhibitors, and decreases likelihood of patients death or delays initiation of dialysis by 40%.
Dietary adjustments in subjects with chronic renal failure are complex because multiple nutrient modifications are required and changes in lifestyle must be maintained for years. Furthermore, low-protein diet is considered tedious, unpalatable and difficult to achieve. This has an obvious negative influence on the quality of life of patients and makes their adherence to the new therapeutic prescriptions more difficult. In fact, the difficulty to reach patients' compliance is well known. There is ample evidence that poor adherence is considered a critical barrier to treatment success and remains one of the leading challenges to healthcare professionals. Few data are available in clinical practice concerning the patients' compliance to low protein diet. A dietary interview method is a validated instrument to evaluate the practice and routines related to the assessment of nutrient intake in nondialyzed CKD patients and to obtain the patients' compliance. However, the interview requires the presence of a dedicated dietitian and a lot of his time.
For these reasons, and because of the absence of dedicated dietitians in many nephrology centres, it is usual practice to give standard low protein diets to CKD patients not on dialysis.
Aim of this study was to verify if few simple tips were able to reduce protein, phosphate and sodium intake in patients with CKD, as compared to the practice of giving a low protein diet elaborated by a renal dietitian.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The 6-point diet is a list of six items indicating how to modify their dietary habits:
Classical low-protein diet prescribed according to the patients' desired body weight (DBW), obtained by multiplying the squared value of the height times a reference BMI value of 23. These diets contained at least 30 kcal/kg/day (25 in overweight patients), with a dietary sodium intake restricted to 2.5 g/day.
Time frame: 6 months
Evaluation of modification of GFR and proteinuria
Time frame: 6 months
Evaluation of the modifications of serum urea nitrogen, sodium, potassium, phosphate, bicarbonate, parathormone , urinary urea nitrogen, phosphate, potassium, sodium, protein and phosphate intake
Time frame: 6 months
Evaluation of modifications of total protein, albumin, C-reactive protein, body weight, BMI
Time frame: 6 months
The compliance was defined by a constant protein intake between 0.7 and 0.9 g/kg B.W. throughout the study
Federico II University
Other
Effects of the 6-point Diet on the Metabolic Control, the Compliance and the Nutritional Status of CKD Patients Stage 3b-5
Acronym: PIS
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