UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study of anti-aging effects of supplement intake
Acronym	Study of anti-aging effects
Scientific Title	Exploratory study of anti-aging effects of supplement intake
Scientific Title:Acronym	Study of anti-aging effects
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploratory evaluation of the anti-aging effect of supplements taken continuously for 4 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mitochondrial number (mtDNA / gDNA), sirt1 gene expression level (sirt1 mRNA / GAPDH mRNA)
Key secondary outcomes	Urinary 8-OHdG, urinary pentosidine, blood fatty acid fraction, blood e-NAMPT, saliva Sirt2, intestinal flora, oral flora Options *: Age-related gene/protein expression levels (melatonin, GH/IGF-1, polyamine, DHEA-S, BDNF, etc.), telomere length, hexanoyl lysine (HEL), isolastan, CoQ10 oxidation rate, peroxidation Lipid (LPO), total antioxidant capacity (STAS, PAO), T cell count, T cell proliferation coefficient, CD4/CD8 T cell ratio, naive T cell count, naive/memory T cell ratio, B cell count, NK cell count, CD8 + CD28 + T cell count, methylated DNA, vitamin C, folic acid, rutin, zeaxanthin, beta-cryptoxanthin, lycopene, alpha-carotene, beta-carotene, vitamin A, tocopherol, ubiquinol, cortisol, luteinizing hormone, follicle Stimulant hormone, oxidatively denatured LDL (LAB), soluble LOX-1 *: Optional evaluation items will be judged from the measurement results of the default primary evaluation items and secondary evaluation items, and will be implemented as necessary.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Device,equipment
Interventions/Control_1	Group I: Take 2 capsules of test food A * continuously for 4 weeks around 10 am (on an empty stomach between meals). *Test food A is either NMN-containing supplement or placebo.
Interventions/Control_2	Group I: Take 2 capsules of test food B * continuously for 4 weeks around 10 am (on an empty stomach between meals). *Test food B is either NMN-containing supplement or placebo.
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	45 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Men and women aged 45 to 64 at the time of consent
Key exclusion criteria	1.Persons who have chronic illness, receiving medication, have a serious disease history 2.Persons who are allergic to the test food 3.Persons who are breast-feeding, pregnant, or who plan or wish to become pregnant during the study period. 4.Persons who regularly use medicines, foods for specified health use, and health foods etc. that may affect aging, such as drugs with antioxidant activity 5.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 6.Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takamasa Middle name Last name Masuda
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Email	masudat@hc-sys.jp

Public contact
Name of contact person	1st name Takamasa Middle name Last name Masuda
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Homepage URL
Email	masudat@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization	MIRAILAB BIOSCIENCE Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel	03-6809-2722
Email	soumu@hc-sys.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	2021 Year 03 Month 12 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	60
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 03 Month 08 Day
Date of IRB	2021 Year 03 Month 08 Day
Anticipated trial start date	2021 Year 03 Month 15 Day
Last follow-up date	2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 12 Day
Last modified on	2021 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049782