UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024877 |
|---|---|
| Receipt number | R000028627 |
| Scientific Title | Effect of wheat bran supplement intake on human intestinal enviroment |
| Date of disclosure of the study information | 2016/11/17 |
| Last modified on | 2016/11/17 15:23:52 |
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Basic information
Public title
Effect of wheat bran supplement intake on human intestinal enviroment
Acronym
Effect of wheat bran intake on the intestinal enviroment
Scientific Title
Effect of wheat bran supplement intake on human intestinal enviroment
Scientific Title:Acronym
Effect of wheat bran intake on the intestinal enviroment
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the functionality of wheat bran
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anlysis of fecal samples on day 0, 7, 14, 21 and 28.
Key secondary outcomes
Anlysis of blood sample on day 0 and 28.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects take the wheat bran supplements including 6 g of dietry fiber per day for 4 weeks.
Interventions/Control_2
Subjects will take the wheat bran supplements including 12 g of dietry fiber per 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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Females from 20 to 25 years of age
2) Informed consent provided.
Key exclusion criteria
1) Subjects who are allergic to the test food of this trial.
2) Subjects who are pregnant, lactating, or planning to get pregnant.
3) Subjects judged by the investigator/project leader to be ineligible for other reasons.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ohashi Norio |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka, Japan
TEL
054-264-5553
ohashi@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ohashi Norio |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka, Japan
TEL
054-264-5553
Homepage URL
ohashi@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Nisshin pharma inc.
Organization
Division
Category of Funding Organization
Profit 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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 27 | 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
| 2016 | Year | 11 | Month | 17 | Day |
Last modified on
| 2016 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028627
