UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060255 |
|---|---|
| Receipt number | R000068920 |
| Scientific Title | Safety Evaluation of Excessive Intake of Maizinol (UP165) in Healthy Adults: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2026/01/05 10:12:11 |
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Basic information
Public title
Safety Evaluation of Excessive Intake of Maizinol (UP165) in Healthy Adults
Acronym
Safety Evaluation of Excessive Intake of Maizinol (UP165) in Healthy Adults
Scientific Title
Safety Evaluation of Excessive Intake of Maizinol (UP165) in Healthy Adults: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Safety Evaluation of Excessive Intake of Maizinol (UP165) in Healthy Adults
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of Maizinol (UP165) following 4 weeks of excessive intake in healthy adults, focusing on adverse events and changes in clinical laboratory parameters.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Incidence of adverse events during the intervention period.
Key secondary outcomes
1. Incidence of new abnormal values in urine tests or blood parameters relative to baseline.
2. Descriptive changes in physical measurements, urinalysis, and blood biochemistry.
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Maizinol (UP165), 2500 mg/day, 20 capsules/day for 4 weeks
Interventions/Control_2
Placebo (Dextrin), 20 capsules/day 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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged between 18 and 75
4. Healthy individuals
5. Individuals who are willing and able to provide informed consent and comply with all study procedures
6. Individuals who maintain a stable lifestyle, including regular meals, exercise, and sleep schedules
7. Individuals who are willing to refrain from taking any new supplements, functional foods, or medicines that may affect sleep or mood during the study period.
8. Individuals who are not allergic to corn or corn products related to the test product
9. Individuals who are able to understand and communicate in the language used in the informed consent and research materials
10. Individuals who are not currently or recently participating in other clinical trials
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking or using medicines (including herbal medicines) or supplements
6. Individuals who are allergic to medicines or foods related to the test product, particularly those who are allergic to corn or corn products
7. Individuals who are pregnant, lactating, or planning to become pregnant during this study
8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
9. Individuals who are shift workers
10. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Unigen Inc.
Institute
Department
Personal name
Funding Source
Organization
Unigen Inc.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068920
