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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021309
Receipt No. R000024575
Official scientific title of the study 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 2016/08/04

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Basic information
Official scientific title of the study 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.
Title of the study (Brief title) 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 Hiroshi Itoh
Organization Keio University School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology
Address 35 Shinanomachi, Shinjuku, Tokyo, JAPAN
TEL 03-5363-3797
Email hiito@z8.keio.jp

Public contact
Name of contact person Junichiro Irie
Organization Keio University School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology
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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 03 Month 03 Day
Anticipated trial start date
2016 Year 03 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2016 Year 03 Month 03 Day
Last modified on
2016 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024575

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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