UMIN-CTR Clinical Trial

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
Email	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
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040436