UMIN-CTR Clinical Trial

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 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	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	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	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	49
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	2017 Year 07 Month 31 Day
Date of IRB	2017 Year 07 Month 04 Day
Anticipated trial start date	2017 Year 08 Month 04 Day
Last follow-up date	2022 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	2017 Year 08 Month 31 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=R000032622