UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of rice protein supplement on nutritional and metabolic status in prevalent hemodialysis patients: a randomized double-blind cross-over study
Title of the study (Brief title)	Niigata KOME (key evaluation of rice proteins' medical benefits) study 3
Region	Japan

Condition
Condition	End stage kidney disease requiring maintenance hemodialysis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of rice protein supplement on nutritional and metabolic status in prevalent hemodialysis patients with low protein intake
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in protein intake estimated by normalized protein nitrogen appearance (nPNA)
Key secondary outcomes	1) Objective score of nutrition on dialysis 2) Body composition estimates using direct segmental multi-frequency bioelectrical impedance analysis (Inbody720, Biospace, Tokyo, Japan) 3) Self-reported adherence to the allocated supplement 4) Change in dietary patterns assessed by brief-type self- administered diet history questionnaire 5) Laboratory parameters associated with bone and mineral disorder (e.g. calcium, phosphate, parathyroid hormone, and fibroblast growth hormone 23 6) Uric acid 7) Gastrointestinal symptoms such as appetite loss, abdominal pain, diarrhea and constipation

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Once-daily jelly supplement containing 5 g rice protein for 4 weeks
Interventions/Control_2	Once-daily jelly supplement not containing rice protein for 4 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult prevalent hemodialysis patients who fulfill the following criteria will be included in the study: 1) Serum albumin concentration of< (or =) 3.8mg/dl 2) Body mass index of > (or =) 19 and <23 kg/m2 3) Dry weight 6 months ago is within 95-105% of current one 4) Normalized protein equivalent of nitrogen appearance (nPNA) of < 1.2g/kg/day 5) Those who have undergone maintenance hemodialysis for more than 2 years 6) Those who have given written informed consent on the use of their data for the study
Key exclusion criteria	1) Those with severe heart or liver disease 3) Those at perioperative stages, or those with severe infection or serious injury 4) Those with food allergy 5) Those who are considered not eligible for the study by attending doctors due to any medical reasons
Target sample size	50

Research contact person
Name of lead principal investigator	Akihiko Saito
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Applied Molecular Medicine
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL	025-227-0915
Email

Public contact
Name of contact person	Akihiko Saito
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Applied Molecular Medicine
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL	025-227-0915
Homepage URL
Email	akisaito@med.niigata-u.ac.jp

Sponsor
Institute	Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	The Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	新潟大学医歯学総合病院(新潟県)、信楽園病院(新潟県)、向陽メディカルクリニック(新潟県)

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 17 Day
Anticipated trial start date	2013 Year 07 Month 29 Day
Last follow-up date	2014 Year 02 Month 28 Day
Date of closure to data entry	2014 Year 04 Month 01 Day
Date trial data considered complete	2014 Year 05 Month 01 Day
Date analysis concluded	2014 Year 06 Month 01 Day

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

Management information
Registered date	2013 Year 06 Month 04 Day
Last modified on	2016 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012726