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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045657
Receipt No. R000052096
Scientific Title An Exploratory Research on the Functionality of Amino Acid Mixed Foods for Healthy Adult Women with Skin Aging Problems
Date of disclosure of the study information 2021/10/05
Last modified on 2021/10/04

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Basic information
Public title An Exploratory Research on the Functionality of Amino Acid Mixed Foods for Healthy Adult Women with Skin Aging Problems
Acronym An Exploratory Research on the Functionality of Amino Acid Mixed Foods for Healthy Adult Women with Skin Aging Problems
Scientific Title An Exploratory Research on the Functionality of Amino Acid Mixed Foods for Healthy Adult Women with Skin Aging Problems
Scientific Title:Acronym An Exploratory Research on the Functionality of Amino Acid Mixed Foods 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 In this study, subjects intake test food A or test food B for 8 consecutive weeks. The purpose of this study is to verify the index of skin aging and its effect on the inhibitory effect of pentosidine production.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fluorescent AGEs (AF), Skin viscoelasticity,Transepidermal water loss,Moisture of the skin surface,VISIA score,Skin color quantification,Observation for skin condition by dermatologists, Blood AGEs(Pentosidine)
Key secondary outcomes Fasting blood glucose level, Glycated albumin,HbA1c, Anti-Aging QOL Common Questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
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 Intake test food A for 8 weeks
Interventions/Control_2 Intake test food B for 8 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]with skin disease,such as atopic dermatitis.
[3]with strange skin conditions at measurement points.
[4]used a drug to treat a disease in the past 1 month.
[5]have a history of and/or contract serious diseases (eg,liver disease,kidney disease, heart disease,lung disease,blood disease).
[6]have a history and/or contract digestive disease.
[7]with serious anemia.
[8]whose BMI are 30 or more.
[9]have allergic reaction to ingredients of test foods and other foods or drugs.
[10]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 test periods.
[11]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 test periods.
[12]have a habit to use drugs claiming to improve skin function in the past 3 months.
[13]are or are possibly pregnant, or are breastfeeding
[14]drink more than 60g/day on average in terms of pure alcohol.
[15]with psychiatric disease.
[16]are smokers.
[17]with possible changes of life style during test periods.
[18]will develop seasonal allergy symptoms, such as pollinosis, use an anti-allergic drug.
[19]neglect skin care.
[20]can't avoid direct sunlight exposure, such as sunburn, during test periods.
[21]had been conducted an operation or beauty treatment on the test spot in the past 6 months.
[22]are participating and/or had participated in other clinical studies within the last 3 months.
[23]are judged as not appropriate to this study by a responsible doctor.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Yoshikazu
Middle name
Last name Yonei
Organization Faculty of Life and Medical Sciences,Doshisha University
Division name Anti-Aging Medical Research Center
Zip code 6100394
Address 1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL 0774-65-6394
Email yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name Toshiyasu
Middle name
Last name Tamura
Organization TES Holdings Co., Ltd.
Division name Department of Clinical Trial
Zip code 1100015
Address 6F,Kairaku Bldg,2-7-5 Higashi-Ueno,Taitou-ku,Tokyo
TEL 03-6801-8400
Homepage URL
Email info@tes-h.co.jp

Sponsor
Institute Anti-Aging Bank Co.,Ltd.
Institute
Department

Funding Source
Organization Ajinomoto Co.,Inc.
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 Society of Glycative Stress Research
Address 5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel 03-6709-8842
Email 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 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
2021 Year 10 Month 05 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
2021 Year 10 Month 01 Day
Date of IRB
2021 Year 10 Month 01 Day
Anticipated trial start date
2021 Year 10 Month 08 Day
Last follow-up date
2021 Year 12 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
2021 Year 10 Month 04 Day
Last modified on
2021 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052096

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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