UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043616 |
|---|---|
| Receipt number | R000049802 |
| Scientific Title | A study for safety of excessive intake of supplements Open-label study |
| Date of disclosure of the study information | 2021/03/15 |
| Last modified on | 2025/03/04 12:50:59 |
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Basic information
Public title
A study for safety of excessive intake of supplements
Open-label study
Acronym
A study for safety of excessive intake of supplements
Scientific Title
A study for safety of excessive intake of supplements
Open-label study
Scientific Title:Acronym
A study for safety of excessive intake of supplements
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate safety by overdose (triple) the test food to the subject.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event
Physical examination
Hematological test
Blood biochemical test
Urinalysis
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
Ingestion of test food 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
(1) Subjects of men and women aged 20 to 64
(2) Subjects with a BMI of less than 30 kg / m2
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria
(1) Persons with a history of liver disease, renal disease, digestive system disease, heart disease, diabetes, or other diseases that may affect the results of this study, or subjects with a history of surgery
(2) Subjects with abnormal liver function and renal function test values
(3) Subjects with diseases currently being treated
(4) Subjects with food and drug allergies
(5) Subjects with anemia symptoms
(6) Subjects who play intense sports and subjects who are on a diet
(7) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(8) Subjects who are continuously treated with medicines (including OTC and prescription drugs)
(9) Subjects who are excessively ingesting alcohol
(10) Subjects who cannot stop drinking from the day before the test to the day of the test
(11) Pregnant subjects or subjects who are planning to become pregnant or breastfeed during the test period
(12) Subjects who are participating in or will participate in other clinical trials at the start of this study.
(13) Other subjects judged by the investigator to be inappropriate
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
530-0044
Address
Higashitenma buildng 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
0661355200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
530-0044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
0648018917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Kantoshimbunhanbai Inc.
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
Miura Clinic, Medical Corporation Kanonkai IRB
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
0661355200
mterashima@oneness-sup.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
| 2021 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
15
Results
The principal investigator determined that there were no safety concerns with the test food.
Results date posted
| 2025 | Year | 03 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The selected subject background was as follows:
Age 44.2 12.6 years
Male 8 participants
Female 7 participants
Total 15 participants
Participant flow
Out of 31 participants screened, 15 were enrolled. However, one participant dropped out due to personal reasons, resulting in 14 participants being included in the analysis.
Adverse events
During the test food intake period, nine adverse events were reported; however, they were determined to have no causal relationship with the test food.
Outcome measures
Adverse event
Physical examination
Clinical laboratory test or Clinical examination
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | 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 | 03 | Month | 15 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049802
