UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049332 |
|---|---|
| Receipt number | R000055935 |
| Scientific Title | Efficacy Evaluation of Supplement |
| Date of disclosure of the study information | 2022/10/31 |
| Last modified on | 2023/06/02 09:59:56 |
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Basic information
Public title
Efficacy Evaluation of Supplement
Acronym
Efficacy Evaluation of Supplement
Scientific Title
Efficacy Evaluation of Supplement
Scientific Title:Acronym
Efficacy Evaluation of Supplement
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of NMN-containing supplement intake for 12 weeks on telomere length in healthy women(40 to 60 years old).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Telomere length
Key secondary outcomes
SIRT1 mRNA
Natural killer cell activity
Analysis of wrinkles using VISIA
Evaluation of Wrinkle Grade
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
NMN-containing supplement, 2 tablets a day, 12 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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1. Healthy Japanese females aged 40-60 years at the time of giving informed consent.
2. Individuals who has freely given consent and has understood the purpose of the study.
3. Individuals who can understand and comply with the rules written in protocol during the study period.
4. Individuals who are considered fit for the enrollment in this study.
Key exclusion criteria
1. Individuals who have current or history of food allergies or asthma.
2. Individuals who regularly take medicines that may affect the test.
3. Individuals who regularly take health foods, supplements that may affect the test.
4. Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
5. Individuals with a current or history of serious diseases (hepatic, renal, cardiovascular, hematologic, urological, gynecological).
6. Individuals with severe anemia.
7. Individuals who participate in other clinical trials.
8. Individuals judged inappropriate for this study by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Fujii |
Organization
NICCA CHEMICAL CO.,LTD.
Division name
Cosmetics Research Dept.
Zip code
910-8670
Address
4-23-1 Bunkyo, Fukui-shi, Fukui
TEL
0776-25-8582
y-fujii@demicosmetics.com
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Fujii |
Organization
NICCA CHEMICAL CO.,LTD.
Division name
Cosmetics Research Dept.
Zip code
910-8670
Address
4-23-1 Bunkyo, Fukui-shi, Fukui
TEL
0776-25-8582
Homepage URL
y-fujii@demicosmetics.com
Sponsor or person
Institute
Research Center for Immunological Analysis, Inc.
Institute
Department
Personal name
Funding Source
Organization
NICCA CHEMICAL CO.,LTD.
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
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama
Tel
0868-54-1199
rt2067@yamada-bee.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 | 10 | Month | 31 | 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
11
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
| 2022 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055935
