UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021309 |
|---|---|
| Receipt number | R000024575 |
| Scientific Title | Assessment of the safety of nicotinamide mononucleotide (NMN) in healthy subjects; phase I study. The clinical trial to evaluate metabolic-syndrome-related parameters to develop NMN as Foods with Function Claims. |
| Date of disclosure of the study information | 2016/03/03 |
| Last modified on | 2019/10/06 01:58:51 |
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Basic information
Public title
Assessment of the safety of nicotinamide mononucleotide (NMN) in healthy subjects; phase I study.
The clinical trial to evaluate metabolic-syndrome-related parameters to develop NMN as Foods with Function Claims.
Acronym
Assessment of the safety of nicotinamide mononucleotide (NMN).
Scientific Title
Assessment of the safety of nicotinamide mononucleotide (NMN) in healthy subjects; phase I study.
The clinical trial to evaluate metabolic-syndrome-related parameters to develop NMN as Foods with Function Claims.
Scientific Title:Acronym
Assessment of the safety of nicotinamide mononucleotide (NMN).
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the safety and kinetics of NMN in healthy subjects.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
the safety of NMN (physical and laboratory examinations).
Key secondary outcomes
the kinetics of NMN.
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
the single intake of NMN.
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
the healthy subjects who agree to the study.
Key exclusion criteria
1 the subjects with a previous history of diseases.
2 the subjects with malignant neoplasms.
3 the subjects with serious infections.
4 the subjects with psychiatric disorders.
5 the subjects with ophthalmic disorder.
6 the subjects with allergic disorders.
7 the subjects who are regarded as inadequate by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Itoh |
Organization
Keio University School of Medicine
Division name
Division of Endocrinology, Metabolism and Nephrology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
TEL
03-5363-3797
hiito@z8.keio.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Irie |
Organization
Keio University School of Medicine
Division name
Division of Endocrinology, Metabolism and Nephrology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
TEL
03-5363-3797
Homepage URL
j-irie@z8.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research ethics committee, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
Tel
03-5363-3611
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 03 | 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
10
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
| 2016 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2016 | Year | 03 | Month | 03 | Day |
Last modified on
| 2019 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024575
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
