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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024246
Receipt No. 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

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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
Email 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
Email reiko-naito@kenkoin.jp

Sponsor
Institute FANCL Corporation
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027909

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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