UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026044 |
|---|---|
| Receipt number | R000029853 |
| Scientific Title | Suppressive effect of functional rice on the postprandial serum triglyceride level-A randomized, double blind, and cross-over study- |
| Date of disclosure of the study information | 2017/02/09 |
| Last modified on | 2017/04/27 09:54:25 |
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Basic information
Public title
Suppressive effect of functional rice on the postprandial serum triglyceride level-A randomized, double blind, and cross-over study-
Acronym
Suppressive effect of functional rice on the postprandial serum triglyceride level
Scientific Title
Suppressive effect of functional rice on the postprandial serum triglyceride level-A randomized, double blind, and cross-over study-
Scientific Title:Acronym
Suppressive effect of functional rice on the postprandial serum triglyceride level
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to verify the suppressive effect of functional rice on postprandial serum triglyceride level
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve (AUC) of postprandial serum triglyceride level
Key secondary outcomes
Postprandial serum triglyceride levels and remnant like lipoprotein particle cholesterol levels and their AUC
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
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 function rice- wash out- intake of control (Placebo) rice
Interventions/Control_2
Intake of control (placebo) rice- wash out- intake of function 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who have ability to conscent
2)Subjects aged from 20 to less than or equal to 64years old
3)Subjects whose fasting serum triglyceride levels are less than 200 mg/dL
Key exclusion criteria
1) Subjects who have history of serious disease or resection of their gastrointestinal tract.
2) Subjects who routinely use medicine, FOSHU, and/or health food.
3) Subjects who have allergy to test food and/or high fat meal and extreme lactose intolerance or diarrhea.
4) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
5) Heavy user of alcohol or excessive smoker
6) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical pharmacology center
Zip code
Address
61-1 Sin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839, Japan
TEL
001-882-0111
takano@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isao Takehara |
Organization
Clinical Support Corporation
Division name
Food Division
Zip code
Address
Minami 1 jou Nishi, Chuo-ku, Sapporo city, Hokkaido, Japan
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
医療法人北武会 美しが丘病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 09 | 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
| 2017 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 10 | 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
| 2017 | Year | 02 | Month | 08 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029853
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
