UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley
Acronym	The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley
Scientific Title	The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley
Scientific Title:Acronym	The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to investigate the effect of barley intake of glucose tolerance change and intestinal environmental change in adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Area under the curve of blood glucose and blood insulin in glucose tolerance test during 2weeks and 4 weeks of consumption
Key secondary outcomes	1)Incremental area under the curve of blood glucose and blood insulin in glucose tolerance test during 2weeks and 4 weeks of consumption 2)Blood glucose and blood insulin in glucose tolerance test during 2weeks and 4 weeks of consumption 3)Improving effect of intestinal environment (bowel movement, intestinal microflora, intestinal metabolite) during 2weeks and 4 weeks of consumption 4)Questionnaire of physical feeling during 2weeks and 4 weeks of consumption

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are 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	Test food intake for 4 weeks - Washout 4 weeks - Control food intake for 4 weeks
Interventions/Control_2	Control food intake for 4 weeks - Washout 4 weeks - Test food intake for 4 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	50 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Males and females aged 50 to 69 years old. 2) Subjects whose body mass index (BMI) is included between 18 kg/m2 to less than 25 kg/m2. 3)Subjects whose fasting blood glucose level is under 109 mg/dL. 4) Subjects who don't take fermented foods, dietary fibers and supplements regularly. 5) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	1)Subjects who didn't undergo abdominal surgical operation within 6 month before test start. 2)Subjects who didn't take antibiotics for 1 month or more within 6 month before test start. 3)Subjects who have allergy to test food. 4)Smokers 5)Subjects whose consort or partner also participates to same clinical test. 6)Subjects who plan big change of lifestyle during test period. 7)Subjects with tendency of chronic diarrhea. 8)Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart. 9)Subjects who suspected chronic or serious infectious disease. 10)Premenopausal women. 11)Subjects who participated the other clinical test within 1 month before test start. 12)Subjects who donated over 200 mL blood and/or blood components within the last one month to the current study. 13)Males who donated over 400 mL blood within the last three month to the current study. 14)Females who donated over 400 mL blood within the last four month to the current study. 15) Males who will be collected over 1200 mL blood, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 16) Females who will be collected over 800 mL blood, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 17)Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Katsuhisa Middle name Last name Sakano
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Plan Sales Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	MetaGen, Inc. Hakubaku co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hakubaku co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.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 08 Month 18 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	2016 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date	2016 Year 08 Month 19 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	2016 Year 08 Month 18 Day
Last modified on	2020 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027267