UMIN-CTR Clinical Trial

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
Email	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
Email	j-irie@z8.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024575