UMIN-CTR Clinical Trial

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 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 pref., 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 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	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	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	Completed
Date of protocol fixation	2019 Year 01 Month 07 Day
Date of IRB	2019 Year 01 Month 11 Day
Anticipated trial start date	2019 Year 01 Month 11 Day
Last follow-up date	2024 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	2019 Year 02 Month 07 Day
Last modified on	2022 Year 09 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040781