Efficacy of the 6-point Diet

NCT01865526 | Completed

• 2 other identifiers: PISCarlo Romano
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease; Low protein diet; CKD stage 3b-5

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

Six point diet DIETARY_SUPPLEMENT

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.

Six point diet

Low protein diet DIETARY_SUPPLEMENT

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.

Low protein diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

federico II university, department of nephrology

Naples, Naples, 80129, Italy

Location

Related Publications (1)

• 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.

  PMID: 26453483 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• eleonora riccio, md

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: May 31, 2013
• Study Start: March 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 31, 2013

Record last verified: 2012-12

Locations

IT (1)