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

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 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

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

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
Registered date File name

Research case data
Registered date File name