UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053058 |
|---|---|
| Receipt number | R000060544 |
| Scientific Title | An exploratory study of the efficacy of an amino acid mix food under low-dose conditions in healthy adult women with skin aging problems. |
| Date of disclosure of the study information | 2024/01/18 |
| Last modified on | 2024/01/17 09:22:50 |
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Basic information
Public title
An exploratory study of the efficacy of an amino acid mix food under low-dose conditions in healthy adult women with skin aging problems.
Acronym
An exploratory study of the efficacy of an amino acid mix food under low-dose conditions in healthy adult women with skin aging problems.
Scientific Title
An exploratory study of the efficacy of an amino acid mix food under low-dose conditions in healthy adult women with skin aging problems.
Scientific Title:Acronym
An exploratory study of the efficacy of an amino acid mix food under low-dose conditions in 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 12 weeks of continuous intake of test food A (food containing medium doses of amino acids) and test food B (food containing low doses of amino acids) on skin aging-related indices under low-dose conditions of amino acid-mixed foods. We will also examine the safety of the test foods during 12 weeks of consumption.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluorescent AGEs (AF),Skin viscoelasticity, VISIA score, Skin color quantification, Observation for skin condition by dermatologists, Skin Awareness Questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
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 A for 12 weeks.
Interventions/Control_2
Subjects will consume the test food B 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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Female aged between 40 and 60 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 whose written informed consent has been obtained.
[5]Individuals who can come to the designated venue for this study and be inspected.
[6]Individuals judged appropriate for this study by a responsible doctor.
Key exclusion criteria
Individuals (who)
[1]contract disease and are under treatment.
[2]undergoing hormone replacement procedures.
[3]with skin disease,such as atopic dermatitis.
[4]with strange skin conditions at measurement points.
[5]used a drug to treat a disease in the past 1 month.
[6]have a history of and/or contract serious diseases (eg,liver disease,kidney disease, heart disease,lung disease,blood disease).
[7]have a history and/or contract digestive disease.
[8]with psychiatric disease.
[9]with serious anemia.
[10]whose BMI are 30 or more.
[11]have allergic reaction to ingredients of test foods and other foods or drugs.
[12]have a habit to use functional foods and/or supplements containing collagen, specified amino acids in the past 3 months and/or are planning to use those foods during study periods.
[13]have a habit to use Foods with Function Claims, functional foods and/or supplements claiming to improve skin function and/or Anti-glycation in the past 3 months and/or are planning to use those foods during study periods.
[14]have a habit to use drugs claiming to improve skin function in the past 3 months.
[15]are or are possibly pregnant, or are breastfeeding.
[16]are smokers.
[17]drink more than 60g/day on average in terms of pure alcohol.
[18]with possible changes of life style during study periods.
[19]will develop seasonal allergy symptoms, such as pollinosis, use an anti-allergic drug.
[20]neglect skin care.
[21]have undergone or will undergo facial cosmetic procedures such as facial peels, laser or other facial cosmetic treatments, beauty treatments at esthetic clinics, spas, etc., or facial art makeup in the past 4 weeks or during study period.
[22]can't avoid direct sunlight exposure, such as sunburn, during study periods.
[23]are participating and/or had participated in other clinical studies within the last 3 months.
[24]are judged as not appropriate to this study by a responsible doctor.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Ueda |
Organization
Ajinomoto Co.,Inc.
Division name
Planning Group, Amino Acids Dept.
Zip code
104-8315
Address
15-1, Kyobashi 1-chome, Chuo-ku,104-8315, Japan
TEL
03-5250-8111
takuji.ueda.z7a@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,101-0054, Japan
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 Subjects Examination Deliberation Committee
Address
15-1, Kyobashi 1-chome, Chuo-ku, 104-8315, Japan
Tel
0352508111
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
| 2024 | Year | 01 | Month | 18 | 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
| 2023 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 05 | 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
| 2023 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060544
