UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054099 |
|---|---|
| Receipt number | R000061786 |
| Scientific Title | A verification study to evaluate the safety of excessive consumption of SAC-containing garlic supplements : an open-label study |
| Date of disclosure of the study information | 2024/04/30 |
| Last modified on | 2024/04/10 09:58:51 |
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Basic information
Public title
A verification study to evaluate the safety of excessive consumption of SAC-containing garlic supplements
Acronym
A verification study to evaluate the safety of excessive consumption of SAC-containing garlic supplements
Scientific Title
A verification study to evaluate the safety of excessive consumption of SAC-containing garlic supplements : an open-label study
Scientific Title:Acronym
A verification study to evaluate the safety of excessive consumption of SAC-containing garlic supplements
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety of consuming five times the normal intake level for four weeks in healthy adults.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematological examination
Urinalysis
Key secondary outcomes
Adverse event
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
To intake SAC-containing garlic supplements 5 tablets(10mg) / day 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) persons who are 20 years old or older
(2) persons who is generally judged as healthy
(3) Persons who can give voluntary written consent to participate in the present trial
Key exclusion criteria
(a) persons who have changed their habitats to take supplements within past 4 weeks
(b) Persons who work in night shift or in day and night shift
(c) persons who have been treated their illness or prevention in a clinic at their informed consent
(d) persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system
(e) persons with the medical histories of alcoholism or drug dependence
(f) persons who might be developed allergic reaction to foods.
(g) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period
(h) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(i) persons who will not be judged suitable to the participants by the investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kouichirou |
| Middle name | |
| Last name | Ohnuki |
Organization
Kindai University
Division name
Faculty of humanity-oriented science and engineering
Zip code
820-0011
Address
11-6,Kayanomori,Iiduka-shi,Fukuoka,Japan
TEL
0948-22-5655
ohnuki@fuk.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Ohnuki |
Organization
User Life Science Co.,Ltd.
Division name
The research and development part
Zip code
820-0115
Address
372-3,Niho,Iiduka-shi,Fukuoka,Japan
TEL
0948-82-3123
Homepage URL
userlifescience@gmail.com
Sponsor or person
Institute
User Life Science Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Bizen Chemical 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
Kindai University, Faculty of humanity-oriented science and engineering, Ethics Committee
Address
11-6,Kayanomori,Iiduka-shi,Fukuoka,Japan
Tel
0948-22-5655
ohnuki@fuk.kindai.ac.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
九州大学病院キャンパス（福岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
https://userlife.science/clinical/clinical-protocols/overdose/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.bizen-c.co.jp/assets/img/development/paper/SAC_safety20240409.pdf
Number of participants that the trial has enrolled
15
Results
(1) Hematological examination
There were several items with significant differences between pre- and post-intake, but all remained within the range of the reference values.
(2) Urinalysis
No clinically significant fluctuations were observed in any of the items
Results date posted
| 2024 | Year | 04 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
8 males, 7 females
Age(mean): 36.4
Good health status
Participant flow
Screening: No specific procedures were conducted, and healthy adults participated as subjects.
Consent obtained: 15 individuals Allocation : None
Analysis population: 15 individuals
Adverse events
No adverse events
Outcome measures
Hematological examination
Urinalysis
Adverse event
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061786
