Efficacy of the 6-point Diet
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Six point diet; Low protein diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The 6-point diet is a list of six items indicating how to modify their dietary habits:
Do not add salt at table and for cooking;
Food to avoid: any kind of salami, sausages, cheese and dairy products or canned food;
Replace noodle or bread with special no-protein food;
The second course (meat, fish and eggs) are allowed once a day in the usual quantity;
4-5 servings/day of fruits or vegetables are suggested;
Once or twice a week the main course may be of "normal" noodle with legumes instead of the second course, with fruit and vegetables.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic kidney disease; Low protein diet; CKD stage 3b-5