UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044645 |
|---|---|
| Receipt number | R000050994 |
| Scientific Title | Safety evaluation of excessive intake of supplements for healthy adults |
| Date of disclosure of the study information | 2022/08/20 |
| Last modified on | 2024/07/08 10:21:25 |
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Basic information
Public title
Safety evaluation
Acronym
Safety evaluation
Scientific Title
Safety evaluation of excessive intake of supplements for healthy adults
Scientific Title:Acronym
Safety evaluation of excessive intake of supplements for healthy adults
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety of excessive intake of the supplement, 5-fold quantity of recommended daily intake, for 4 weeks
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test, Biochemical test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before the study and at weeks 2 and 4 after using the test food. Adverse events thorough the study
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the supplement, 5-fold quantity of recommended daily intake, for 4 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females from 20 to 64 years old
Key exclusion criteria
(1) Subjects who are judged as unsuitable for the study based on the results of the lifestyle questionnaire
(2) Subjects who constantly use health foods richly containing the involvement ingredients
(3) Subjects having a disease requiring treatments or a history of serious diseases for which medication was required
(4) Subjects having possibilities for emerging allergy related to the study
(5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination before the study
(6) Subjects who had participated in other clinical studies within one month before the study or are planned to participate in other clinical studies after informed consent for the study
(7) Subjects who intend to become pregnant or lactating during the test period
(8) Subjects judged as unsuitable for the study by the principle investigator for other reasons
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Yamato |
Organization
Medical Corporation Kouwakai Kouwa Clinic
Division name
Internal medicine, Director
Zip code
170-0003
Address
6-33-17, Komagome, Toyoshima-ku, Tokyo
TEL
03-3917-8105
info@kouwakai.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yasui |
Organization
EP Mediate Co., Ltd.
Division name
Development Business Headquarters, TTC Center, Trial Planning Department
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
03-5657-4983
Homepage URL
yasui475@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Greenyn Biotechnology Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
saito876@eps.co.jp
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
| 2022 | Year | 08 | Month | 20 | 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
| 2021 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050994
