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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000035802
Receipt No. R000040781
Scientific Title Metabolic effects of barley intake
Date of disclosure of the study information 2019/02/28
Last modified on 2019/02/07

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Basic information
Public title Metabolic effects of barley intake
Acronym Metabolic effects of barley intake
Scientific Title Metabolic effects of barley intake
Scientific Title:Acronym Metabolic 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 blood glucose level after barley intake
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in blood glucose level up to 120 minutes after ingestion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 To intake 1 pack of barley rice
Interventions/Control_2 To intake 1 pack of 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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) healthy adults
2) male and female
3) 20-80 years old
4) informed consent
Key exclusion criteria 1) Persons who develop an allergic reaction to barley
2) Those who have gastrointestinal disorder, or who routinely have diarrhea and feces close to liquid state
3) Person under taking medication for treating diabetes
4) Persons with severe illness
5) Participating in this research, persons who can not obtain written consent based on their own free will
6) Others who have judged that the research director is inappropriate as the subject
Target sample size 20

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 pref., 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 pref., 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, Food Industry Affairs Bureau.
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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 28 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 Suspended
Date of protocol fixation
2019 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 07 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
2019 Year 02 Month 07 Day
Last modified on
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040781

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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