UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015710 |
|---|---|
| Receipt number | R000018251 |
| Scientific Title | Crossover study on blood cholesterol reduction by pregelatinized brown rice ingested |
| Date of disclosure of the study information | 2014/11/19 |
| Last modified on | 2015/09/10 19:39:30 |
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Basic information
Public title
Crossover study on blood cholesterol reduction by pregelatinized brown rice ingested
Acronym
A Study of blood cholesterol reduction of by pregelatinized brown rice ingested
Scientific Title
Crossover study on blood cholesterol reduction by pregelatinized brown rice ingested
Scientific Title:Acronym
A Study of blood cholesterol reduction of by pregelatinized brown rice ingested
Region
| Japan |
Condition
Condition
LDL cholesterol 120 ~ 159 mg / dL and, BMI 23 ~ 30. Healthy people.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pregelatinized brown rice intake reveals for blood cholesterol reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total cholesterol and LDL cholesterol in the blood
Key secondary outcomes
Body weight, subcutaneous fat area, visceral fat area, blood sugar, hemoglobin A1c, blood pressure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
pregelatinized brown rice
Interventions/Control_2
cooked rice
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
LDL-cholesterol 120-159mg/dL and BMI 23 to BMI 30 (exclusive of BMI 30)
Key exclusion criteria
The person whom a principal investigator in charge judged to be inappropriate as asubject.It is during diabetes, dyslipidemia, high blood pressure treatment now.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Yamamoto |
Organization
Tokyo University of Agriculture
Division name
Department of Applied Biology and Chemistry
Zip code
Address
Sakuragaoka 1-1-1,Setagaya-ku,Tokyo
TEL
03-5477-2320
yujiya@nodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Tsujii |
Organization
Tokyo University of Agriculture
Division name
Department of Applied Biology and Chemistry
Zip code
Address
Sakuragaoka 1-1-1,Setagaya-ku,Tokyo
TEL
03-5477-2325
Homepage URL
96tsujii@nodai.ac.jp
Sponsor or person
Institute
Hitachi health management center
Institute
Department
Personal name
Funding Source
Organization
Alpha-Foods Co., Ltd.,
Organization
Division
Category of Funding Organization
Profit 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
日立健康管理センタ Hitachi health management center
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 19 | 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
| 2014 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 17 | Day |
Last modified on
| 2015 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018251
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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