UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of new sprout of grape extract on secretion of antimicrobial peptide and gut flora balance.
Title of the study (Brief title)	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	Takayuki Hosoi
Organization	Kenkoin Medical Corporation Foundation Kenkoin Clinic
Division name	Director
Address	6-7-4 Ginza, Chuo-ku, Tokyo, Japan
TEL	03-3573-1153
Email	takayuki-hosoi@kenkoin.jp

Public contact
Name of contact person	Reiko Naito
Organization	Kenkoin Medical Corporation Foundation
Division name	Kenkoin Clinic
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027909