UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056554 |
|---|---|
| Receipt number | R000064578 |
| Scientific Title | Safety confirmation test of overdose of Agaricus extract |
| Date of disclosure of the study information | 2025/01/07 |
| Last modified on | 2025/06/16 17:52:03 |
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Basic information
Public title
Safety confirmation test of overdose of Agaricus extract
Acronym
Safety confirmation test of overdose of Agaricus extract
Scientific Title
Safety confirmation test of overdose of Agaricus extract
Scientific Title:Acronym
Safety confirmation test of overdose of Agaricus extract
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of overdose of the test food in healthy adult.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events
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 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese male and female subjects between the ages of 20 and 65 at the time of written consent.
2) Subject who has received a full explanation of the purpose and content of the study, has the ability to consent, understand the study well, and has volunteered to participate in the study and has agreed to participate in the study in writing.
Key exclusion criteria
1) Subject who is taking medication or under medical treatment.
2) Subject who is under exercise therapy or dietetic therapy.
3) Subject who is allergic to any food, pollen, or other allergens, regardless of the test food.
4) Subject with current or history of drug dependence or alcohol dependence.
5) Subject who is hospitalized for mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea, etc.), or have a history of mental disorders in the past.
6) Subject with irregular life rhythms due to night shifts or shift work.
7) Subject with extremely irregular lifestyle habits such as eating and sleeping.
8) Subject who is or may be under the influence of alcohol to an excessive degree.
9) Subject who has an extremely unbalanced diet.
10) Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease. (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have.
11) Subject who has had abnormal or concerning liver function values (gamma-GTP, AST, ALT) indicated in previous health checkups, etc.
12) Subject who uses health foods, supplements, and medicines.
13) Subject who has participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period.
14) Subject who has collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition.
15) Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
16) Subject who has difficulty observing records on various survey forms.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Nozaki |
Organization
BHN Co., Ltd.
Division name
Research and Development Dept. R&D Center
Zip code
230-0046
Address
Room 302, 75-1 Ono-cho, Tsurumi-ku, Yokohama City, Kanagawa, 230-46, Japan
TEL
045-947-4371
t-nozaki@bhn.co.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
M&I Science CORP.
Division name
Clinical Development Department
Zip code
531-0001
Address
Pacific Marks Nishi Umeda 4F, 2-6-60 Umeda, Kita-ku, Osaka City, Osaka, Japan
TEL
06-7878-6780
Homepage URL
m.matsuoka@mis21.co.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
others
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
Ethics Review Committee, Tokyo Shinjuku Clinic
Address
SIL Shinjuku Bldg. 5F, 2-46-3 Kabukicho, Shinjuku-ku, Tokyo, Japan
Tel
03-6709-6071
irb@ml.taifukukai.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
| 2025 | Year | 01 | Month | 07 | 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
| 2024 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
17) Subject who is judged as an inappropriate candidate according to the screening data.
18) Subject who is considered as an inappropriate candidate by the doctor in charge.
Management information
Registered date
| 2024 | Year | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064578
