UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008923
Receipt number R000010463
Scientific Title Study on the usefulness of rice proteins in Japanese obese patients
Date of disclosure of the study information 2012/09/18
Last modified on 2015/09/15 13:29:47

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Basic information

Public title

Study on the usefulness of rice proteins in Japanese obese patients

Acronym

Niiagata KOME (key evaluation of rice proteins' medical benefits) study 1

Scientific Title

Study on the usefulness of rice proteins in Japanese obese patients

Scientific Title:Acronym

Niiagata KOME (key evaluation of rice proteins' medical benefits) study 1

Region

Japan


Condition

Condition

Obesity

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prospectively evaluate the efficacy of rice proteins or casein in controlling lipid and glucose metabolism and renal function as well as their safety in Japanese obese subjects.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in markers of lipid metabolism 4 and 8 weeks after the beginning

Key secondary outcomes

Changes in the following parameters during the observation period:
•Liver and renal function (urinary albumin/creatinine, eGFR etc)
•Blood pressure
•Body weight, body mass index and waist circumference

Evaluation of the safety during the study period; Frequency of adverse events
Adverse events are analyzed with Common Terminology Criteria for Adverse Events v4.0-JCOG when they happen.


Exploratory analysis;
Inflammation concerned with nutritional status is evaluated by the analysis of oxidative stress markers including 8-OHdG. Novel biomakers including urinary megalin are measured and analyzed for the association with other markers.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of rice proteins (10g/day) for 4 weeks

Interventions/Control_2

Intake of casein(10g/day) 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

Those who fulfill the following criteria will be included in the study:
1) Male or female obese subjects with BMI> or = 25kg/m2 or subjects with metabolic syndrome (visceral obesity)
2) Those who have given written informed consent on the use of their data for the study

Key exclusion criteria

Those who meet any of the following criteria will be excluded from the study:
1) Those who are under treatment for diabetes mellitus or hypertension
2) Those with severe heart, renal 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

30


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)、コープケミカル診療所(新潟県)


Other administrative information

Date of disclosure of the study information

2012 Year 09 Month 18 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

2012 Year 07 Month 04 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 01 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry

2014 Year 04 Month 30 Day

Date trial data considered complete

2014 Year 05 Month 31 Day

Date analysis concluded

2014 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2012 Year 09 Month 15 Day

Last modified on

2015 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010463


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name