UMIN-CTR Clinical Trial

Basic information
Public title	A study evaluating various aging markers by taking NMN supplements
Acronym	A study evaluating various aging markers by taking NMN supplements
Scientific Title	A study evaluating various aging markers by taking NMN supplements
Scientific Title:Acronym	A study evaluating various aging markers by taking NMN supplements
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate various aging markers for NMN supplements.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IGF-1, DHEA-s, E2, Free testosterone, cortisol, TSH, FT3, FT4, Insulin, NMN, NAD, Sirt1 mRNA
Key secondary outcomes	Immunity judgment test,Measurement of fluorescent AGEs (AGE reader),Skin VAS questionnaire

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	Take a supplement containing 300 mg of NMN for 8 weeks.
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	50 years-old <=
Age-upper limit	80 years-old >
Gender	Female
Key inclusion criteria	[1] Postmenopausal women aged 50 to 79 at the time of consent to participate in the study [2]Individuals who are healthy and are not received treatment of disease [3]Individuals whose written informed consent has been obtained [4]Individuals who can come to the designated examination date and receive the examination [5]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [3]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [4]Individuals with history of gastrointestinal disorders except for appendicitis [5]Individuals with skin disease symptoms such as atopic dermatitis [6]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [7]Individuals who have experienced mood disorder or condition deterioration due to blood sampling in the past [8]Individuals with serious anemia [9]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [11]Individuals whose life style will change during the test period (ex. travel for a long time) [12]Individuals who participated in other clinical studies in the past three months [13]Individuals judged inappropriate for the study by the principal
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Morita
Organization	Renais Crinic Nihonbashi
Division name	Director
Zip code	103-0022
Address	3-3-1 Nihonbashi Muromachi, Chuo-ku, Tokyo
TEL	03-6665-0888
Email	ymorita707@yahoo.co.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Morita
Organization	Renais Crinic Nihonbashi
Division name	Director
Zip code	103-0022
Address	3-3-1 Nihonbashi Muromachi, Chuo-ku, Tokyo
TEL	03-6665-0888
Homepage URL
Email	ymorita707@yahoo.co.jp

Sponsor
Institute	Renais Crinic Nihonbashi
Institute
Department

Funding Source
Organization	Renais Crinic Nihonbashi
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Society of Glycative Stress Research
Address	5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel	03-6709-8842
Email	rinri-glycativestress@antiaging-bank.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	医療法人美健会ルネスクリニック日本橋

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 07 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	17
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	2021 Year 08 Month 26 Day
Date of IRB	2021 Year 09 Month 06 Day
Anticipated trial start date	2021 Year 09 Month 08 Day
Last follow-up date	2021 Year 12 Month 20 Day
Date of closure to data entry	2021 Year 12 Month 21 Day
Date trial data considered complete	2021 Year 12 Month 22 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 02 Day
Last modified on	2022 Year 01 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051774