UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014276 |
|---|---|
| Receipt number | R000016631 |
| Scientific Title | An exploratory study to identify factors associated with continuous intake of partially abraded brown rice and brown rice. |
| Date of disclosure of the study information | 2014/06/16 |
| Last modified on | 2015/01/21 14:55:11 |
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Basic information
Public title
An exploratory study to identify factors associated with continuous intake of partially abraded brown rice and brown rice.
Acronym
Continuous intake pilot study of partially abraded brown rice
Scientific Title
An exploratory study to identify factors associated with continuous intake of partially abraded brown rice and brown rice.
Scientific Title:Acronym
Continuous intake pilot study of partially abraded brown rice
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the intake volume, frequencies, and continuous duration of partially abraded brown rice compared with those of brown rice. Furthermore, to identify factors associated with continuous intake of partially abraded brown rice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
feeding rate
Key secondary outcomes
1. Amount of test meal consumption
2. Total eating frequencies of test meals
3. Cooking conditions of rice
4. Lifestyle behavior
5. Dietary habit (Eating pattern was evaluated by brief-type self-administered diet history questionnaire:BDHQ)
6. Height, Weight, Abdominal circumference
7. Blood pressure
8. Biomarkers(fasting blood gulcose, HbA1c, insulin, TG, HDL-cholesterol, LDL-cholesterol, total cholesterol, AST, ALT, gamma-GTP, BUN, Cr, UA, FFA, TP, Alb)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Brown rice(4 weeks),
Partially abraded brown rice(4 weeks)
Interventions/Control_2
Partially abraded brown rice(4 weeks), Brown rice(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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 40 - 64 years.
2. Capable of giving informed consent.
Key exclusion criteria
1. Fasting glucose not less than 126 mg/dL.
2. HbA1c not less than 6.5%.
3. Subjects who are receiving pharmacotherapy for chronic disease.
4. Current smokers.
5. Subjects who were recognized unsuitable for this study by the Investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Hashimoto |
Organization
University of Tsukuba
Faculty of Medicene
Division name
Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3064
koichi.hashimoto@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Hashimoto |
Organization
University of Tsukuba
Division name
Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3064
Homepage URL
koichi.hashimoto@md.tsukuba.ac.jp
Sponsor or person
Institute
Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Fuculty of Medicine
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization (NARO)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Ibaraki Prefecture,
Yamato Sangyo Co.Ltd,
Metabolism and Endocrinology University of Tsukuba,
National Food Research Institute
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 16 | 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 | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 26 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 16 | Day |
Last modified on
| 2015 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016631
| 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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| Registered date | File name |
