Efficacy of the 6-point Diet | NCT01865526

NCT01865526

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
Carlo Romano	Other Identifier	Ethic commettee

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low protein diet	Active Comparator	The patients of this group received a classical low protein diet (LPD),according to their desired body weight (DBW), obtained by multiplying the squared value of the height times a reference body mass index (BMI) value of 23. LPD were individually prepared and explained to the patients by a dedicated dietician and contained at least 30 kcal/kg/day (25 in overweight patients), with a dietary sodium intake restricted to 2.5 g/day.	Dietary Supplement: Low protein diet
Six point diet	Experimental	These patients were assigned to receive the 6-points-diet, and were given by the Nephrologist the list of six items indicating how to modify their dietary habits; all the items were thoroughly explained and discussed with the patients	Dietary Supplement: Six point diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Six point diet	Dietary Supplement	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect on renal disease progression	Evaluation of modification of GFR and proteinuria	6 months
Effect on metabolic control	Evaluation of the modifications of serum urea nitrogen, sodium, potassium, phosphate, bicarbonate, parathormone , urinary urea nitrogen, phosphate, potassium, sodium, protein and phosphate intake	6 months
Effect on nutritional status	Evaluation of modifications of total protein, albumin, C-reactive protein, body weight, BMI	6 months
Effect on patients'compliance to the dietetic therapy	The compliance was defined by a constant protein intake between 0.7 and 0.9 g/kg B.W. throughout the study	6 months

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
eleonora riccio, md	Federico II University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
federico II university, department of nephrology		Naples	Naples	80129	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26453483	Derived	Pisani A, Riccio E, Bellizzi V, Caputo DL, Mozzillo G, Amato M, Andreucci M, Cianciaruso B, Sabbatini M. 6-tips diet: a simplified dietary approach in patients with chronic renal disease. A clinical randomized trial. Clin Exp Nephrol. 2016 Jun;20(3):433-42. doi: 10.1007/s10157-015-1172-5. Epub 2015 Oct 9.

Condition Browse Module

ID	Term
D051436	Renal Insufficiency, Chronic

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Intervention Browse Module

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747