UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017485 |
|---|---|
| Receipt number | R000019023 |
| Scientific Title | Clinical investigation on metabolically-beneficial effects by brewed non-alcoholic beverage derived from brown rice |
| Date of disclosure of the study information | 2015/05/31 |
| Last modified on | 2015/05/10 17:44:32 |
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Basic information
Public title
Clinical investigation on metabolically-beneficial effects by brewed non-alcoholic beverage derived from brown rice
Acronym
Clinical investigation on beverage derived from brown rice
Scientific Title
Clinical investigation on metabolically-beneficial effects by brewed non-alcoholic beverage derived from brown rice
Scientific Title:Acronym
Clinical investigation on beverage derived from brown rice
Region
| Japan |
Condition
Condition
person with metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate metabolic impct of gamma-oryzanol on fuel homeostasis and balance of intestinal microbiota
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Anthropometric measurement(body weight,abdominal girth,blood pressure) and metabolc parameters(plasma levels of glucose,insulin,lipids,the marker of urinary oxidation stress and fecal analyses(intestinal microbiota).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Investigation of brewed non-alcoholic beverage derived from brown rice for 4weeks.
Interventions/Control_2
Investigation of brewed non-alcoholic beverage derived from white rice for 4weeks.
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
Subjects who are obese (BMI>25 or waist circumference>85) and who are taking medication about any two of the following metaboic derangement : (1)dyslipidemia, (2)hypertention, (3)impaired glucose tolerance.
Key exclusion criteria
1)Subjects who undertake medication to influence on study results
2)Subjects who have infectious diseases or history of recent operation and injury
3)Expected, pregnant or nursing womens
4)Subjects who have severe renal,liver or other organ dysfunction
5)Subjects who are not suitable for this examination for some medical reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Masuzaki, MD, phD |
Organization
Graduate School of Medicine, University of the Ryukyus
Division name
Second Department of Internal Medicine
Zip code
Address
207 Uehara, Nishihara, Okinawa, 903-0215, Japan
TEL
098-895-1146
hiroaki@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Yonamine, MD |
Organization
Graduate School of Medicine, University of the Ryukyus
Division name
Second Department of Internal Medicine
Zip code
Address
207 Uehara, Nishihara, Okinawa, 903-0215, Japan
TEL
098-895-1146
Homepage URL
osaraba4ma@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, University of the Ryukyus, Second Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
沖縄県健康づくり財団 (Okinawa Health Promotion Foundation)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 31 | 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 | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 10 | Day |
Last modified on
| 2015 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019023
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
