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
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
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
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
