UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Validation study for improvement of colon deterioration by BARLEYmax; Randomized double blind placebo control studies
Title of the study (Brief title)	Validation study for improvement of colon deterioration by BARLEYmax
Region	Japan

Condition
Condition	People with tend to be colon deterioration
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We focus attention on BARLEYmax with rich content of multi dietary fibre and conduct human trial to evaluate intestinal regulation , skin improvement, glucose tolerance, immunity and intestinal fermentation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Defecation frequency, 2.Stool output
Key secondary outcomes	1.Amount of short chain fatty acid in stool, 2.Measurement of intestinal flora, 3.Analysis of expired gas, 4.Blood test(insulin, glucose, total cholesterol, LDL-cholesterol, neutral fat, free fatty acid), 5.Skin moisture, skin fitness, skin water loss, 6.Degree of colon deterioration

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Treatment
Type of intervention	Food
Interventions/Control_1	Short bar incorporated in BARLEYmax(Amount of BARLEYmax intake:12g/day, Intake period:4 weeks)
Interventions/Control_2	Short bar incorporated in wheat(Amount of BARLEYmax intake:0g/day,Intake period: 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	20 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	1.Defecation(2-4 times/week), 2.Meal times(3 times/day), 3.People with tend to be colon deterioration
Key exclusion criteria	1.People who takes antiflatulent and laxative, 2.People who takes functional foods with constipation improvement function at the time of screening(including specified health foods, see Attachment 1), 3.People who takes antibacterial agents and gastrointestinal agents at the time of screening, 4. People who takes probiotics(lactobacillus, bifidobacteria, natto bacteria), food products incorporating oligosaccharide, dietary fibre, functional foods with constipation improvement function(including specified health foods, see Attach 1), and people who can not stop taking food products containing rich content of sugar alchol(see Attachment 2) and food products, supplement containing rich content of barley during test period, 5.People having food allergy, 6.People having disorder required emergency therapy and serious complicating disorder, 7.People having digestive disorder and surgical history, 8.People who is judged as inappropriate by questionnarie, 9.People who is judged as inappropriate by blood test at the time of screeing, 10.People who is pregnant, has pregnancy plan during test period, and is breast feeding, 11.People who has record of drug dependence, alchol dependence and current medical history, 12.People who takes other food products and has plan to join pharmaceutical testing, cosmetic testing and pharmaceuticl coating test, 13.People with treatment of special face care in the last three months(facial treatment, injection of hyaluronic acid, botox, chemical peeling, phototherapy, laser healing), 14.Others. People who is judged as inappropriate by responsible investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshitaka Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Address	9-7, Shibaura 1-chome, Minato-ku, Tokyo 105-0023, Japan
TEL	03-3452-7733
Homepage URL	http://www.kso.co.jp
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	TEIJIN LIMITED Healthcare Business Development
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	医療法人財団健康睡眠会　日本橋循環器科クリニック

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 31 Day
Anticipated trial start date	2016 Year 09 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 02 Month 03 Day
Date analysis concluded	2017 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 13 Day
Last modified on	2017 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027669