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Efficacy of the 6-point Diet

NCT01865526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2013-05-31

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • eleonora riccio, md · Federico II University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01865526 on ClinicalTrials.gov