UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035620 |
|---|---|
| Receipt number | R000040436 |
| Scientific Title | Effect of the Test Food on Skin Quality and Endothelial Function. |
| Date of disclosure of the study information | 2019/01/25 |
| Last modified on | 2019/07/23 17:53:49 |
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Basic information
Public title
Effect of the Test Food on Skin Quality and Endothelial Function.
Acronym
Effect of the Test Food on Skin Quality and Endothelial Function.
Scientific Title
Effect of the Test Food on Skin Quality and Endothelial Function.
Scientific Title:Acronym
Effect of the Test Food on Skin Quality and Endothelial Function.
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effect of the test food on skin quality and endothelial function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Skin viscoelasticity (Week 0, Week 4, Week 8).
Key secondary outcomes
*Secondary indexes
[1]Skin moisture content (Week 0, Week 4, Week 8).
[2]Transepidermal water loss (Week 0, Week 4, Week 8).
[3]Observation for skin condition by dermatologists (Week 0, Week 4, Week 8).
[4]Arterial pressure-volume index, arterial velocity pulse index (Week 0, Week 4, Week 8).
[5]Questionnaire of physical feeling (Week 0, Week 4, Week 8).
*Safety
[1]Weight, body fat percentage, BMI (Week 0, Week 4, Week 8).
[2]Doctor's questions (Week 0, Week 4, Week 8).
*Other index
[1]Subject's diary (each day during the test period).
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test product (2 capsules one time in a day; 16 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]Japanese females aged 40-59 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who are concerning on skin sagging and dullness.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can have an examination in a designated day.
[6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1]Individuals using medical products.
[2]Individuals with skin disease, such as atopic dermatitis.
[3]Individuals with strange skin conditions at measurement points.
[4]Individuals who used or applied a drug for treatment of disease in the past 1 month.
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6]Individual who have digestive organ disease.
[7]Individuals with serious anemia.
[8]Individuals who are sensitive to test product or other foods, and medical products.
[9]Individuals who are or are possibly pregnant, or are lactating.
[10]Individuals who have an addiction to alcohol or a mental illness.
[11]Individuals who are a smoker.
[12]Individuals with possible changes of life style during the test period.
[13]Individuals with probable seasonal allergy during the test period.
[14]Individuals who have severe menopausal symptoms.
[15]Individuals who neglect skin care.
[16]Individuals who cannot avoid daylight exposure during the test period.
[17]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing components of the test product in the past 3 months or will ingest those foods during the test period.
[18] Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[19]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[20]Individuals who had been conducted an operation on the test spot.
[21] Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[22]Individuals judged inappropriate for the study by the principal.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinc
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Center for Pharma-Food Research, Division of Pharmaceutical Sciences. Graduate School of Integrative Pharmaceutical and Nutritional Sciences, University of Shizuoka
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch
Address
1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN
Tel
+81-3-5816-0711
jimukyoku@tes-h.co.jp
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
| 2019 | Year | 01 | Month | 25 | 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
12
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
| 2018 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 22 | Day |
Last modified on
| 2019 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040436
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