UMIN-CTR Clinical Trial

Basic information
Public title	The study to investigate the anti-aging efficacy of intravenous infusion of nicotinamide mononucleotide
Acronym	The study to investigate the anti-aging efficacy of intravenous infusion of NMN
Scientific Title	The study to investigate the anti-aging efficacy of intravenous infusion of nicotinamide mononucleotide
Scientific Title:Acronym	The study to investigate the anti-aging efficacy of intravenous infusion of NMN
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the anti-aging efficacy of intravenous infusion of nicotinamide mononucleotide for healthy individuals
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the skeletal muscle index by the bioelectrical impedence analysis
Key secondary outcomes	To evaluate the parameters related to glucose and lipid metabolism, hormone levels in blood

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The healthy subjects who agree to study
Key exclusion criteria	1.The subjects with malignant neoplasms. 2.The subjects judged as ineligible by clinical investigators
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Akane Middle name Last name Yu
Organization	Sense Skin Clinic
Division name	Sense Skin Clinic
Zip code	221-0052
Address	15-2-2F, Sakaecho, Kanagawa-ku, Yokohama, Kanagawa
TEL	0454446022
Email	akanenaka@hotmail.com

Public contact
Name of contact person	1st name Akane Middle name Last name Yu
Organization	Sense Skin Clinic
Division name	Sense Skin Clinic
Zip code	221-0052
Address	15-2-2F, Sakaecho, Kanagawa-ku, Yokohama, Kanagawa
TEL	0454446022
Homepage URL
Email	akanenaka@hotmail.com

Sponsor
Institute	Sense Skin Clinic
Institute
Department

Funding Source
Organization	Sense Skin Clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Furuta Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Organization for Safety Assessment of Clinical Research
Address	13-16 Sanjominami-cho, Ashiya, Hyogo, Japan
Tel	0797-22-5511
Email	info@sacrj.com

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	2022 Year 12 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
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	Enrolling by invitation
Date of protocol fixation	2020 Year 09 Month 30 Day
Date of IRB	2022 Year 07 Month 27 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To evaluate the parameters related to lipid and glucose metabolism, hormone levels in blood

Management information
Registered date	2022 Year 12 Month 02 Day
Last modified on	2022 Year 12 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056578