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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024877
Receipt No. 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

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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
Email 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
Email ohashi@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028627

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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