UMIN-CTR Clinical Trial

Basic information
Public title	Study for the Effects of a Test Food on Skin Function.
Acronym	Study for the Effects of a Test Food on Skin Function.
Scientific Title	Study for the Effects of a Test Food on Skin Function.
Scientific Title:Acronym	Study for the Effects of a Test Food on Skin Function.
Region	Japan

Condition
Condition	No(Healthy adults)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines effects of a test food on skin function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Indexes for skin function. [1]Transepidermal water loss (Week 0, Week 8). [2]Skin moisture content (Week 0, Week 8).
Key secondary outcomes	*Secondary indexes [1] Skin viscoelasticity (Week 0, Week 8). [2] Observation for skin condition by dermatologists (Week 0, Week 8). [3] Skin Age measurement (Week 0, Week 8). [4] Plasma pentosidine (Week 0, Week 8). [5] Visual Analogue Scale (Week 0, Week 4, Week 8). *Safety [1] Blood pressure, pulsation (Week 0, Week 8). [2] Weight, body fat percentage, BMI (Week 0, Week 8). [3] Blood test (Week 0, Week 8). [4] Blood biochemical test (Week 0, Week 8). [5] Urine analysis (Week 0, Week 8). [6] Doctor's questions (Week 0, Week 8). [7] Adverse events: number of cases and expression rate of adverse events (Week 8). [8] Subject's diary (From the first day of ingestion of a test material to the last day of the test).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral intake of the test product A (10 capsules in a day; 8 weeks).
Interventions/Control_2	Oral intake of the test product B (10 capsules in a day; 8 weeks).
Interventions/Control_3	Oral intake of the placebo product (10 capsules in a day; 8 weeks).
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	65 years-old >
Gender	Female
Key inclusion criteria	[1] Healthy Japanese females aged 40-64 years. [2] Individuals who are healthy and have no chronic physical disease including skin disease. [3] Individuals who are aware of skin dryness. [4] Individuals whose written informed consent has been obtained after explanation of this study. [5] Individuals who can have an examination on a designated check day [6] Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1] Individuals using medical products. [2] Individuals with strange skin conditions at measurement points. [3] Individuals with strange skin conditions at measurement points. [4] Individuals who used a drug to treat a disease in the past 1 month. [5] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [6] Individuals who contract or have a history of serious gastrointestinal disease. [7] Individuals with serious anemia. [8] Individuals whose BMI is over 30 kg/m2. [9] Individuals who are sensitive to test product or other foods, and medical products. [10]Individuals who have a habit to ingest or use health-promoting foods, or supplements containing similar composition with a test food in the past 3 months or will ingest those foods during the test period. [11] Individuals who are or are possibly pregnant, or are lactating. [12] Individuals who excessively take alcohol. [13] Individuals who are patient or have a history of psychiatric disease. [14] Individuals who are a smoker. [15] Individuals who work in sales or delivery, and who engage in outdoor activities and are exposed UV radiation in their daily lives. [16] Individuals with possible changes of life style during the test period. [17] Individuals who will develop seasonal allergy symptoms like hay fever and use a drug. [18] Individuals who neglect skin care. [19] Individuals who will get sunburned during the test period. [20] Individuals who had been conducted an operation or beauty treatment on the test spot in the past 6 months. [21] Individuals who participated in other clinical studies in the past 3 months. [22] Individuals judged inappropriate for the study by the principal.
Target sample size	39

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	S&B FOODS 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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81-3-6240-1162
Email	i.takahashi@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	2023 Year 04 Month 17 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	Completed
Date of protocol fixation	2021 Year 12 Month 27 Day
Date of IRB	2022 Year 01 Month 20 Day
Anticipated trial start date	2022 Year 02 Month 18 Day
Last follow-up date	2022 Year 04 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 02 Month 07 Day
Last modified on	2022 Year 11 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053369