UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061927 |
|---|---|
| Receipt number | R000070802 |
| Scientific Title | Evaluation and Validation Study Using Specific Analytical Methods to Assess the Pharmacokinetics of NMN (two types) Following a Single Oral Dose: A Parallel Study |
| Date of disclosure of the study information | 2026/06/17 |
| Last modified on | 2026/06/16 13:13:57 |
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Basic information
Public title
Exploratory Study on NAD+ Measurement Techniques Following NMN (Two Types) Intake
Acronym
Exploratory Study on NAD+ Measurement Techniques Following NMN (Two Types) Intake
Scientific Title
Evaluation and Validation Study Using Specific Analytical Methods to Assess the Pharmacokinetics of NMN (two types) Following a Single Oral Dose: A Parallel Study
Scientific Title:Acronym
Validation Testing of Analytical Techniques for NMN (two types)
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Whole blood NAD levels and eight types of NMN-related metabolites
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Whole blood NAD levels over time
Key secondary outcomes
Changes in whole blood NMN-related metabolites (eight types) levels over time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Type 1 NMN 350mg
Interventions/Control_2
Type 2 NMN 250mg
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
| 35 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy individuals
2.Individuals who, having fully understood the purpose and content of the study, consent to participate of their own free will
Key exclusion criteria
1.Individuals with an acute illness or currently undergoing treatment for such an illness
2.Individuals with a blood disorder
3.Individuals currently suffering from a symptomatic infectious disease on the test day
4.Individuals who regularly consume health supplements containing NMN
5.Individuals who are pregnant or breastfeeding
6.Individuals currently participating in other clinical trials or similar studies
7.Any other individuals deemed unsuitable as subjects by the treating physician or the principal investigator
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Iwasaki |
Organization
DHC Corporation
Division name
Supplements Unit
Zip code
261-0025
Address
2-42 Hamada, Mihama-ku, Chiba-city, Chiba
TEL
0432754811
hiiwasaki@dhc.co.jp
Public contact
Name of contact person
| 1st name | Nami |
| Middle name | |
| Last name | Harada |
Organization
DHC Corporation
Division name
Supplements Unit
Zip code
261-0025
Address
2-42 Hamada, Mihama-ku, Chiba-city, Chiba
TEL
0432754811
Homepage URL
nharada@dhc.co.jp
Sponsor or person
Institute
DHC Corporation
Institute
Department
Personal name
Funding Source
Organization
Self-financing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
DHC Ethics Review Committee
Address
Mitamachi Terrace 19F, 5-34-2 Shiba, Minato-ku, Tokyo, Japan
Tel
03-3457-5311
ml-ethicsoffice@dhc.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 | 06 | Month | 17 | 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
5
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2026 | Year | 06 | Month | 16 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070802
