UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033201 |
|---|---|
| Receipt number | 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 09:24:32 |
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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
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
sugino@soiken.com
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037856
