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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024624
Receipt No. R000028331
Scientific Title Effects of barley intake, a pilot study
Date of disclosure of the study information 2016/10/31
Last modified on 2019/09/27

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Basic information
Public title Effects of barley intake, a pilot study
Acronym Effects of barley intake
Scientific Title Effects of barley intake, a pilot study
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 after barley intake.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes four weeks later from intake initiation.
levels of serum lipids
Key secondary outcomes levels of serum proteins, carbohydrates and minerals.
enteral environment
bowel habit

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Effects of barley intake in healthy volunteers for four weeks
Interventions/Control_2 Intake two meals of rice cooked with barley per day
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
35 years-old >
Gender Male and Female
Key inclusion criteria healthy adults
male and female
20-35 years old
informed consent
Key exclusion criteria 1) allergy for the barley
2) therapeutic drugs routinely
3) digestive system disease
4) diarrhea tendency
5) feces of almost a liquid state routinely
6) not agreement
7) others
Target sample size 30

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

Sponsor
Institute Nagano Prefecture Next-generation Health Care Industry Council
Institute
Department

Funding Source
Organization Ministry of Agriculture, Forestry and Fisheries
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 Shinshu University School of Medicine
Address Asahi 3-1-1, Matsumoto, Nagano
Tel 0263-37-2572
Email mdrinri@shinshu-u.ac.jp

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 10 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 No longer recruiting
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
2016 Year 08 Month 02 Day
Anticipated trial start date
2016 Year 10 Month 31 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 29 Day
Last modified on
2019 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028331

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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