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

April 17, 2019 updated by: The Third Xiangya Hospital of Central South University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Min Liu, M.D.
        • Principal Investigator:
          • Hao Zhang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low protein diet plus α-keto acid
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
0.4-0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets
Other Names:
  • low protein diet

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Xiangya Hospital of Central South University

Investigators

  • Study Director: Min Liu, M.D., specify unaffiliated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 7, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YYK-2016001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

During the experiment, investigators will share the development in the website.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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