UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062680 |
|---|---|
| Receipt number | R000071675 |
| Scientific Title | Evaluation of the safety of intake of a nutraceutical containing highly concentrated S-1-propenyl-L-cysteine (S1PC) extract powder and NMN |
| Date of disclosure of the study information | 2026/08/25 |
| Last modified on | 2026/08/25 16:44:18 |
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Basic information
Public title
Evaluation of the safety of intake of a nutraceutical containing highly concentrated S-1-propenyl-L-cysteine (S1PC) extract powder and NMN
Acronym
Evaluation of the safety of intake of a nutraceutical IMAI-S1 containing highly concentrated S-1-propenyl-L-cysteine (S1PC) extract powder and NMN
Scientific Title
Evaluation of the safety of intake of a nutraceutical containing highly concentrated S-1-propenyl-L-cysteine (S1PC) extract powder and NMN
Scientific Title:Acronym
Evaluation of the safety of intake of a nutraceutical containing highly concentrated S-1-propenyl-L-cysteine (S1PC) extract powder and NMN
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of intake of the product containing a high concentration of S1PC (20 mg) plus NMN (product name:IMAI-S1) through medical examinations, hematological tests, and blood biochemical tests conducted before, during, and after intake.
To evaluate efficacy by assessing sleep, overall physical condition, and the condition of skin and hair before, during, and after intake, as well as by analyzing plasma and blood cell components, including the concentrations of nicotinamide adenine dinucleotide synthesis-related components in blood cells and plasma, and related activity, such as eNAMPT levels before and after the intake.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Complete blood count, Liver function tests, Renal function tests, Electrolytes, Metabolic profile (lipids,glucose metabolism and uric acid)
Key secondary outcomes
Evaluation of sleep, overall physical condition, and the condition of skin and hair before, during (at 1 week and 2 week), and after intake (4 weeks), as well as by analyzing plasma and blood cell components, including the concentrations of nicotinamide adenine dinucleotide synthesis-related components in blood cells and plasma, and related activity, such as eNAMPT levels before, and after intake (4 weeks).
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of IMAI-S1 (S1PC 20mg and NMN 250mg) for 30 days
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals who have received a full explanation of the purpose and contents of this study, have the capacity to provide consent, have sufficiently understood the explanation, voluntarily wish to participate of their own free will, and have provided written consent to participate.
2. Adult men and women who are aged 40 years or older at the time consent is obtained.
Key exclusion criteria
1. Individuals who have regularly consumed pharmaceuticals or health related products containing nicotinamide adenine dinucleotide intermediate metabolites such as vitamin complexes or nicotinamide mononucleotide or NMN within the past two weeks.
2. Individuals with or suspected of having severe gastrointestinal, hepatic, renal, cardiovascular, hematological, or endocrine disorders, or malignant neoplasms, or a history thereof.
3. Individuals who are breastfeeding or pregnant, or who plan or wish to become pregnant during the study period.
4. Individuals currently taking anticoagulant medication.
5. Individuals with a history of severe allergy to the raw material of the test ingredient (garlic).
6. Individuals otherwise deemed unsuitable for the study by the principal investigator or study collaborators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Taguchi |
Organization
Midtown Clinic Medical Corporation
Division name
Tokyo Midtown Clinic
Zip code
107-6206
Address
Midtown tower 6F, 9-7-1 Akasaka, Minato-ku, Tokyo
TEL
03-5413-7920
j-taguchi@tokyomidtown-mc.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Yada |
Organization
Advanced Medical Care, Inc.
Division name
Well Being Product Business
Zip code
106-0032
Address
Roppongi Hills North Tower 15F, 6-2-31 Roppongi, Minato-ku, Tokyo
TEL
0120-260-386
Homepage URL
IMAI-S1@tokyomidtown-mc.jp
Sponsor or person
Institute
Tokyo Midtown Clinic
Midtown Clinic Medical Corporation
Institute
Department
Personal name
Junichi Taguchi
Funding Source
Organization
Well Being Product Business
Advanced Medical Care, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Institute for Research on Productive Aging; IRPA
Name of secondary funder(s)
LongGen Bioscience Co., Ltd.
Shimadzu Techno-Research, Inc.
IRB Contact (For public release)
Organization
The Ethical Committee of Midtown Clinic Medical Corporation
Address
9-7-1 Akasaka, Minato-ku, Tokyo
Tel
03-5413-0080
k-aramaki@amcare.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
| 2026 | Year | 08 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 25 | Day |
Last modified on
| 2026 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071675
