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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024031
Receipt No. R000027669
Scientific Title Validation study for improvement of colon deterioration by BARLEYmax; Randomized double blind placebo control studies
Date of disclosure of the study information 2016/10/08
Last modified on 2017/03/17

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Basic information
Public title Validation study for improvement of colon deterioration by BARLEYmax; Randomized double blind placebo control studies
Acronym Validation study for improvement of colon deterioration by BARLEYmax
Scientific Title Validation study for improvement of colon deterioration by BARLEYmax; Randomized double blind placebo control studies
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshitaka Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code
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
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code
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)

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 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

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 08 Month 31 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027669

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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