UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024246 |
|---|---|
| Receipt number | R000027909 |
| Scientific Title | Effect of new sprout of grape extract on secretion of antimicrobial peptide and gut flora balance. |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2017/04/27 10:14:39 |
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Basic information
Public title
Effect of new sprout of grape extract on secretion of antimicrobial peptide and gut flora balance.
Acronym
A clinical trial to study the effect of trial supplement on intestinal function (VF-01).
Scientific Title
Effect of new sprout of grape extract on secretion of antimicrobial peptide and gut flora balance.
Scientific Title:Acronym
A clinical trial to study the effect of trial supplement on intestinal function (VF-01).
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the trial supplement on concentration of fecal antimicrobial peptide.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of fecal antimicrobial peptide(0w,1w, 4w, 8w)
Key secondary outcomes
Gut flora balance(0w, 1w, 4w, 8w)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food contained 150 mg new sprout of grape extract once day for 8 weeks.
Interventions/Control_2
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age 20-64
2) BMI 18.5-30.0 kg/m*m
3) Subjects who can submit of stool regularly
4) Subjects who giving written informed consent
Key exclusion criteria
1) Subjects who consecutively take dietary supplement or food including resveratrol
2) Subjects who take drug having an effect on improvement of entero bacterial flora or defecation
3) Subjects who visit a hospital for treatment or take medicine for treatment
4) Subjects who can't stop taking dietary supplement or quasi drug from entry to the end of the study
5) Subjects who are planned to participate in other clinical study.
6) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Hosoi |
Organization
Kenkoin Medical Corporation Foundation Kenkoin Clinic
Division name
Director
Zip code
Address
6-7-4 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-3573-1153
takayuki-hosoi@kenkoin.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Naito |
Organization
Kenkoin Medical Corporation Foundation
Division name
Kenkoin Clinic
Zip code
Address
6-7-4 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-3573-1153
Homepage URL
reiko-naito@kenkoin.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation, Research Institute
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido University Faculty of Advanced Life Science, Department of Cell Biological Science
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
医療法人財団健康院 健康院クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | 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
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 | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 11 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 30 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027909
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
