Effects of Low Protein Diet in Preventing the Progression of Chronic Kidney Disease(CKD)---a Prospective Study

Study Overview
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Brief Summary
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The purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (CKD , stage 2 to 5).

Detailed Description
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Dietary protein restriction represents a basic therapeutic approach in chronic kidney disease(CKD), by reducing the accumulation of nitrogen catabolic substances, and by delaying the progress of CKD and proteinuria, but the effects of the low protein diet on renal failure progression rate remain to be determined.The aim of this study is to evaluate the efficacy of low protein diet and α-keto acid tablet in retard the progress of CKD. This is a prospective study, 100 patients who meet inclusion and exclusion criteria will be included. The changes of glomerular filtration rate in CKD and time to renal replacement will be evaluated after 1 year treatment.

Official Title
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Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Behavioral: low protein diet plus α-keto acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic kidney disease in stage 2 to 5 (GFR<60 ml/min/1.73m2) receiving conservative treatment for CKD Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low protein diet plus α-keto acid<br>A comparison of normal diet and low protein diet plus α-keto acid after intervention in the same individual | Behavioral: low protein diet plus α-keto acid<br>* 0.4-0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets<br>* Other names: low protein diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in glomerular filtration rate | Nutritional status, evaluated by nutrition risk screening (NRS 2002), at the start and during the 1st year of investigators' intervention. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to diet | Compliance to diet, defined by the participants' persistence in low protein diet, by outpatient follow-up and telephone follow-up. | 1 year | 
| Nutritional status | Nutritional status, evaluated by nutrition risk screening (NRS 2002), at the start and during the 1st year of investigators' intervention. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Insufficiency, Chronic, Diet, Protein-Restricted