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Efficacy of the 6-point Diet (PIS)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Six point diet
Low protein diet
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, Low protein diet, CKD stage 3b-5

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age >18 years
  • a basal value of estimated GFR (eGFR) < 45 ml/min/1,73 m2, that had to remain stable during 3 consecutive controls (eGFR variability <15% along 1 month)

Exclusion Criteria:

  • unstable renal function,
  • inability to perform correct 24-hours urine collections,
  • presence of malignancies,
  • treatment with immunosuppressive drugs,
  • pregnancy,
  • congestive heart failure (NYHA class III-IV),
  • proteinuria >3,5 g/24 hours

Sites / Locations

  • federico II university, department of nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Low protein diet

Six point diet

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Effect on renal disease progression
Evaluation of modification of GFR and proteinuria
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
Effect on nutritional status
Evaluation of modifications of total protein, albumin, C-reactive protein, body weight, BMI
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

Secondary Outcome Measures

Full Information

First Posted
May 24, 2013
Last Updated
May 30, 2013
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT01865526
Brief Title
Efficacy of the 6-point Diet
Acronym
PIS
Official Title
Effects of the 6-point Diet on the Metabolic Control, the Compliance and the Nutritional Status of CKD Patients Stage 3b-5
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic kidney disease, Low protein diet, CKD stage 3b-5

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low protein diet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Six point diet
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Six point diet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low protein diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect on renal disease progression
Description
Evaluation of modification of GFR and proteinuria
Time Frame
6 months
Title
Effect on metabolic control
Description
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
Title
Effect on nutritional status
Description
Evaluation of modifications of total protein, albumin, C-reactive protein, body weight, BMI
Time Frame
6 months
Title
Effect on patients'compliance to the dietetic therapy
Description
The compliance was defined by a constant protein intake between 0.7 and 0.9 g/kg B.W. throughout the study
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age >18 years a basal value of estimated GFR (eGFR) < 45 ml/min/1,73 m2, that had to remain stable during 3 consecutive controls (eGFR variability <15% along 1 month) Exclusion Criteria: unstable renal function, inability to perform correct 24-hours urine collections, presence of malignancies, treatment with immunosuppressive drugs, pregnancy, congestive heart failure (NYHA class III-IV), proteinuria >3,5 g/24 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
eleonora riccio, md
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
federico II university, department of nephrology
City
Naples
ZIP/Postal Code
80129
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26453483
Citation
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.
Results Reference
derived

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Efficacy of the 6-point Diet

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