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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010876
Receipt No. R000012726
Scientific Title The effect of rice protein supplement on nutritional and metabolic status in prevalent hemodialysis patients: a randomized double-blind cross-over study
Date of disclosure of the study information 2013/06/10
Last modified on 2016/05/06

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


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

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
1st name
Middle name
Last name Akihiko Saito
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Applied Molecular Medicine
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL 025-227-0915
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Saito
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Applied Molecular Medicine
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 07 Month 17 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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