Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of the 6-point Diet (PIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865526
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Eleonora Riccio, Federico II University

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: Six point diet Dietary Supplement: Low protein diet Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: Low protein diet
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
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.

Experimental: Six point diet
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

The 6-point diet is a list of six items indicating how to modify their dietary habits:

  1. Do not add salt at table and for cooking;
  2. Food to avoid: any kind of salami, sausages, cheese and dairy products or canned food;
  3. Replace noodle or bread with special no-protein food;
  4. The second course (meat, fish and eggs) are allowed once a day in the usual quantity;
  5. 4-5 servings/day of fruits or vegetables are suggested;
  6. Once or twice a week the main course may be of "normal" noodle with legumes instead of the second course, with fruit and vegetables.




Primary Outcome Measures :
  1. Effect on renal disease progression [ Time Frame: 6 months ]
    Evaluation of modification of GFR and proteinuria

  2. Effect on metabolic control [ 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

  3. Effect on nutritional status [ Time Frame: 6 months ]
    Evaluation of modifications of total protein, albumin, C-reactive protein, body weight, BMI

  4. Effect on patients'compliance to the dietetic therapy [ 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865526


Locations
Layout table for location information
Italy
federico II university, department of nephrology
Naples, Italy, 80129
Sponsors and Collaborators
Federico II University
Investigators
Layout table for investigator information
Principal Investigator: eleonora riccio, md Federico II University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eleonora Riccio, MD, Federico II University
ClinicalTrials.gov Identifier: NCT01865526     History of Changes
Other Study ID Numbers: PIS
Carlo Romano ( Other Identifier: Ethic commettee )
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: December 2012
Keywords provided by Eleonora Riccio, Federico II University:
Chronic kidney disease
Low protein diet
CKD stage 3b-5
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency