UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030609 |
|---|---|
| Receipt number | R000034931 |
| Scientific Title | Assessment of the safety of long-term nicotinamide mononucleotide (NMN) in healthy subjects; phase II 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 | 2017/12/29 |
| Last modified on | 2023/07/07 15:48:48 |
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Basic information
Public title
Assessment of the safety of long-term nicotinamide mononucleotide (NMN) in healthy subjects; phase II study.
The clinical trial to evaluate metabolic-syndrome-related parameters to develop NMN as Foods with Function Claims.
Acronym
Assessment of the safety of long-term nicotinamide mononucleotide (NMN).
Scientific Title
Assessment of the safety of long-term nicotinamide mononucleotide (NMN) in healthy subjects; phase II 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 long-term 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 of long-term NMN in healthy subjects and to examine kinetics of metabolites of nicotinamde and the effect of daily administration of NMN on glucose metabolism.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
the safety of long-term (8weeks) NMN (physical and laboratory examinations).
Key secondary outcomes
1.the kinetics of NMN and metabolites of nicotinamide.
2.the effect of daily NMN admnistration on glucose metabolism
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
long-term (8 weeks) 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.
8 the subjects who have obvious abnormality in the screening test
Target sample size
30
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
mitsumasa@keio.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Mitsuishi |
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
mitsumasa@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
ORIENTAL YEAST CO.,LTD
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
Tel
03-3353-1211
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
| 2017 | Year | 12 | Month | 29 | 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
13
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
| 2017 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Resistration in UMIN was closed and have been shifted to jRCT.
The number of clinical trial plan: jRCTs031180242.
Management information
Registered date
| 2017 | Year | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034931
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
