UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045347 |
|---|---|
| Receipt number | R000051774 |
| Scientific Title | A study evaluating various aging markers by taking NMN supplements |
| Date of disclosure of the study information | 2021/09/07 |
| Last modified on | 2022/01/13 10:31:44 |
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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
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
ymorita707@yahoo.co.jp
Sponsor or person
Institute
Renais Crinic Nihonbashi
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051774
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