UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061140 |
|---|---|
| Receipt number | R000069957 |
| Scientific Title | A study to verify the effects of consumption of the test food on anti-aging (blood NAD+, skin, sleep) in healthy Japanese: an open-label study |
| Date of disclosure of the study information | 2026/04/02 |
| Last modified on | 2026/04/02 13:49:07 |
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Basic information
Public title
A study to verify the effects of consumption of the test food on anti-aging (blood NAD+, skin, sleep) in healthy Japanese: an open-label study
Acronym
A study to verify the effects of consumption of the test food on anti-aging (blood NAD+, skin, sleep) in healthy Japanese: an open-label study
Scientific Title
A study to verify the effects of consumption of the test food on anti-aging (blood NAD+, skin, sleep) in healthy Japanese: an open-label study
Scientific Title:Acronym
A study to verify the effects of consumption of the test food on anti-aging (blood NAD+, skin, sleep) in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on anti-aging (blood NAD+, skin, sleep) in healthy Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. OSA sleep inventory MA version
2. Moisture of the skin
3. Viscoelasticity of the skin
4. Blood NAD+
5. Skin tone
6. Microscope
7. Body composition
Key secondary outcomes
1. Individuals who experienced adverse events
2. Individuals whose urinalysis and peripheral blood test values were within the reference range at screening but became outside the reference range after intervention
3. Body composition, urinalysis, and peripheral blood test
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 99 days
Test product: Cell regeneration, Cell repair
Administration: Both Cell regeneration and Cell repair are taken daily. Take four tablets of Cell regeneration 10 minutes before the first meal of the day, and take four tablets of Cell repair 10 minutes before dinner with water per day.
*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Healthy individuals
3. "Women between 30 and 40 years old whose menstrual cycle has been between 25 and 35 days in the past six months" or "Men between 35 and 55 years old"
Key exclusion criteria
Individuals who
1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2.have a pacemaker or an ICD
3.are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4.are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5.are taking or using medications or supplements
6.usually take food/beverage containing functional ingredients which may influence skin (such as GABA, isoflavones, lactic acid bacteria, bifidobacteria, EPA, DHA, astaxanthin, glucosylceramide, proteoglycans, piceatannol, lycoperosides, collagen peptide)
7.are allergic to medicines or foods related to the test product (particularly, apples)
8.have mental health issues such as depression disorder, ADHD, or other issues
9.have irregular sleeping time or habit due to work such as a late-night shift
10.live with their infants less than one year old
11.sleep with their children (1 to 6 years old)
12.live with requiring long-term care persons
13.sleep with more than one person
14.have irregular lifestyles
15.are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome
16.have been diagnosed with atopic dermatitis
17.habitually receive skincare treatment or use instruments for beauty treatment
18.drink to excess every day
19.have undergone cosmetic surgery
20.are pregnant, lactating, or planning to become pregnant during this study
21.have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study
22.are judged as ineligible to participate in this study by the physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
WELLCREATE Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
WELLCREATE Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Futurevita Group Pte. Ltd.
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 02 | Day |
Last modified on
| 2026 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069957
