UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058931 |
|---|---|
| Receipt number | R000067397 |
| Scientific Title | Study on the functionality of an amino acid mix food for healthy adult women with skin aging problems |
| Date of disclosure of the study information | 2025/09/02 |
| Last modified on | 2025/08/29 16:18:45 |
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Basic information
Public title
Study on the functionality of an amino acid mix food for healthy adult women with skin aging problems
Acronym
Study on the functionality of an amino acid mix food for healthy adult women with skin aging problems
Scientific Title
Study on the functionality of an amino acid mix food for healthy adult women with skin aging problems
Scientific Title:Acronym
Study on the functionality of an amino acid mix food for healthy adult women with skin aging problems
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of the test food on indices of skin aging in subjects consuming the food for 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin viscoelasticity R2 and R7 at week 12 of intake
Key secondary outcomes
Skin viscoelasticity(R0,R5,R6),
Transepidermal water loss,Moisture of the skin surface,VISIA score,Skin color quantification,Observation for skin condition by dermatologists,Skin Awareness Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Subjects will consume the test food for 12 weeks.
Interventions/Control_2
Subjects will consume placebo food for 12 weeks.
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Female aged between 30 and 65 at the time of informed consent
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who are aware of skin deterioration such as elasticity and sagging
[4] Individuals who are aware that they consume a lot of carbohydrates
[5]Individuals whose written informed consent has been obtained.
[6]Individuals who can come to the designated venue for this study and be inspected.
[7]Individuals judged appropriate for this study by a responsible doctor.
Key exclusion criteria
Individuals (who)
[1]currently suffering from any disease and undergoing drug treatment.
[2]with atopic dermatitis, skin disease symptoms, and diseases such as liver, kidney, heart, lung, blood, digestive organs, mental disorders, and severe anemia. Also, those with a history of serious illness.
[3]undergoing hormone replacement therapy, and those with menopausal symptoms that have a strong physical and psychological impact.
[4] have a history of taking or applying medications for the purpose of treating a medical condition within the past month (excluding occasional use for headaches, menstrual cramps, colds, etc.)
[5] may be pregnant, pregnant women, breastfeeding women.
[6] may experience allergic symptoms due to ingredients contained in the test food, and individuals who may experience severe allergic symptoms due to other foods or medicines.
[7] have fewer than two bowel movements per week (suspected chronic constipation) and individuals who may use laxatives or constipation medications (including laxatives) during the test period.
[8] have continuously consumed or used foods containing collagen, L-histidine, or L-threonine, or pharmaceuticals, quasi-drugs, specific health use foods, functional foods, health foods, or supplements claiming skin-improving or anti-glycation effects within the past three months, or individuals who plan to consume or use these products during the trial period.
[9]with smoking habits.
[10]with irregular eating habits (e.g., eating only one meal per day, skipping dinner, etc.) or picky eating tendencies.
[11]consume an average of 60g or more of pure alcohol per day.
[12]may need to change their lifestyle during the study period (e.g., night shifts, long-term business trips, etc.).
etc.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Daijiro |
| Middle name | |
| Last name | Ikegami |
Organization
Ajinomoto Co.,Inc.
Division name
Planning Group, Amino Acids Dept.
Zip code
104-8315
Address
15-1, Kyobashi 1-chome, Chuo-ku, Tokyo
TEL
03-5250-8111
daijiro.ikegami.6vb@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Isozaki |
Organization
Anti-Aging Bank Co.,Ltd.
Division name
Clinical trial support team
Zip code
101-0054
Address
3-21,Kanda-nishikicho,Chiyoda-ku,Tokyo
TEL
03-5577-1010
Homepage URL
isozaki@antiaging-bank.com
Sponsor or person
Institute
Ajinomoto Co.,Inc.
Institute
Department
Personal name
Funding Source
Organization
None
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
Ajinomoto Co., Inc. Human Research Ethics Review Board
Address
15-1, Kyobashi 1-chome, Chuo-ku, 104-8315, Japan
Tel
03-5250-8111
ajinomoto_irb@asv.ajinomoto.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
うえのあさがおクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067397
