UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024031 |
|---|---|
| Receipt number | 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 10:10:49 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027669
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
