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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008923
Receipt No. 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

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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
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)、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
URL(English) https://upload.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


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