UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of protein restricted diet on diet adherence and kidney function using portion control plate in patients with chronic kidney disease: A randomized controlled trial
Title of the study (Brief title)	Healthy eating plate CKD trial
Region	Japan

Condition
Condition	Chronic kidney disease (stage: 3-5)
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of a low protein diet on dietary adherence and kidney function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	20% reduction in protein intake
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Protein restriction using portion control plate
Interventions/Control_2	Conventional therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Age 20-64 years 2) Stage 3-5 CKD 3) A outpatients who is prescribed a protein restricted diet by a physician
Key exclusion criteria	1) Communication disorder that diet therapy can not be understand or cognitive impairment 2) A patient who are not suitable for protein restriction due to conditions such as cancer and AIDS 3) A patient who are unsuitable for continuous low protein diet due to acute renal failure. 4) A patient who are considered to be inappropriate for participation in this trial due to other reason by the physician.
Target sample size	104

Research contact person
Name of lead principal investigator	Naoki Sakane
Organization	Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name	Division of Preventive Medicine
Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL	+81-75-641-9161
Email	nsakane@kyotolan.hosp.go.jp

Public contact
Name of contact person	Yamauchi Keiko
Organization	Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name	Division of Preventive Medicine
Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL	+81-75-641-9161
Homepage URL
Email	nsakane@kyotolan.hosp.go.jp

Sponsor
Institute	Division of Preventive Medicine, Clinical Research Institute, Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 15 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 05 Month 15 Day
Anticipated trial start date	2017 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 08 Day
Last modified on	2017 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031335