UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety assessment study on excessive intake of test supplement -A randomized, double blind, placebo controlled, parallel study-
Title of the study (Brief title)	Safety assessment study on excessive intake of test supplement
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to verify the safety assessment on test supplement, 5-fold quantity of recommended daily intake, for consecutive 4 weeks
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety assessment on ingestion of test supplement, 5-fold quantity of recommended daily intake, for consecutive 4 weeks.
Key secondary outcomes

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	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test supplement, 5-fold quantity of recommended daily intake, for 4 weeks
Interventions/Control_2	Intake of placebo, for 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Healthy male and female from 20 to 65 years of age
Key exclusion criteria	1.Subjects who have judged to have problems with participation in examination due to clinical laboratory test values or cardiorespiratory abnormality 2.Subjects who are at risk of developing allergy in relation to the test supplement. 3.Subjects who have a disease requiring regular medication. Subjects who have a history of serious illness requiring medication treatment 4.Subjects whose clinical laboratory values and measured values before ingestion are significantly out of the reference range 5.Subjects who are participating in other clinical trials when start of the examination period 6.Subjects who intend to become pregnant or lactating 7.Subjects who are judged as unsuitable for the study by background survey results 8.Subjects who are judged as unsuitable for the study by the principal doctor
Target sample size	100

Research contact person
Name of lead principal investigator	Kei Yui
Organization	FANCL Corporation
Division name	Research Institute
Address	Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3659
Email	tsubokawa_masaya@fancl.co.jp

Public contact
Name of contact person	Tomohiro Sugino
Organization	Soiken Inc.
Division name	Representative Director
Address	Senri Life Science Center 13F, 1-4-2 Shin-senrihigashimachi, Toyonaka, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 16 Day
Anticipated trial start date	2018 Year 07 Month 21 Day
Last follow-up date
Date of closure to data entry
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	2018 Year 06 Month 29 Day
Last modified on	2019 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037856