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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033201
Receipt No. R000037856
Scientific Title Safety assessment study on excessive intake of test supplement -A randomized, double blind, placebo controlled, parallel study-
Date of disclosure of the study information 2018/07/01
Last modified on 2019/01/04

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Basic information
Public title Safety assessment study on excessive intake of test supplement
-A randomized, double blind, placebo controlled, parallel study-
Acronym Safety assessment study on excessive intake of test supplement
Scientific Title Safety assessment study on excessive intake of test supplement
-A randomized, double blind, placebo controlled, parallel study-
Scientific Title:Acronym 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
1st name
Middle name
Last name Kei Yui
Organization FANCL Corporation
Division name Research Institute
Zip code
Address Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa
TEL 045-820-3659
Email tsubokawa_masaya@fancl.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Sugino
Organization Soiken Inc.
Division name Representative Director
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 01 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
2018 Year 06 Month 16 Day
Date of IRB
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

Other
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

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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