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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028940
Receipt No. R000032622
Scientific Title Effects of barley intake
Date of disclosure of the study information 2017/08/31
Last modified on 2018/04/16

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Basic information
Public title Effects of barley intake
Acronym Effects of barley intake
Scientific Title Effects of barley intake
Scientific Title:Acronym Effects of barley intake
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the changes of the lipid, sugar and protein metabolism, and the enteral environment by the barley consumption
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes levels of serum lipids, carbohydrates and proteins, and bowel habit
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of cooked rice including polished barley for 12 weeks
Interventions/Control_2 Intake of cooked rice for 12 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
35 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Who gave the informed consents in writing after receiving enough explanation of purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.
Key exclusion criteria 1) allergy for the barley
2) regularly use diabetes drugs
3) diarrhea tendency
4) feces of almost a liquid state routinely
5) not agreement to this study
6) others; Who are judged unsuitable for this study by test responsibility doctor.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroya Hidaka
Organization Shinshu University School of Medicine
Division name School of Health Sciences
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano, 390-8621, Japan
TEL 0263-37-2368
Email hiroyan@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Ikegami
Organization Shinshu University School of Medicine
Division name School of Health Sciences
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano, 390-8621, Japan
TEL 0263-37-3507
Homepage URL
Email tikegami@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine
Institute
Department

Funding Source
Organization MAFF(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
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 信州大学医学部(長野県):Shinshu University School of Medicine (Nagano pref.)

Other administrative information
Date of disclosure of the study information
2017 Year 08 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 04 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 08 Month 31 Day
Last modified on
2018 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032622

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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