UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010876
Receipt number 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 17:20:37

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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