UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the Effects and Safety of Applying and Ingesting Test Products on Sliming and Blood Flow.
Title of the study (Brief title)	Examination of the Effects and Safety of Applying and Ingesting Test Products on Sliming and Blood Flow.
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 effects and safety of applying and ingesting test products on sliming and blood flow.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Indexes on sliming (waist girth, hip girth, thigh girth, calf girth, upper arm girth, thigh girth and volume with 3D imaging) (Week 0, Week 4).
Key secondary outcomes	*Secondary indexes [1]Weight, body fat percentage, BMI (Week 0, Week 4) [2]Capillary vessel measurement (Week 0, Week 4) *Safety [1]Blood pressure, pulsation (Week 0, Week 4) [2]Subject's diary (From the first day of ingestion of a test material to the last day of the test) [3]Doctor's questions (Week 0, Week 4)

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 Other
Interventions/Control_1	Using of test product (2 times in a day; 4 weeks) and ingesting of test product (2 tablets in a day; 4 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	20 years-old <=
Age-upper limit	50 years-old >
Gender	Female
Key inclusion criteria	[1]Healthy Japanese females aged 20-50 years. [2]Individuals whose BMI is less than 30. [3]Individuals who worry about thigh girth. [4]Individuals who do not have exercise habits. [5]Individuals whose written informed consent has been obtained. [6]Individuals who can consent a 3D imaging with a paper brassiere and pants. [7]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3]Individuals who used or applied a drug for treatment of disease in the past 1 month. [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [5]Individuals with skin disease, such as atopic dermatitis. [6]Individuals who have sensitive skin. [7]Individuals who are sensitive to a test producer other foods, and medical products. [8]Individuals who are based on average alcohol per 1 day and exceeds 60g/day. [9]Individuals whose life style will change during the test period (ex. travel for a long time). [10]Individuals who had a habit to use and ingest health-promoting foods, foods for specified health uses, health foods, or supplements which call for slimming effects in the past 3 months or will use or ingest those foods during the test period. [11]Individuals who have a history to be treated with an operation to improve skin condition in the past 3 months. [12]Individuals who are or are possibly pregnant, or are lactating. [13]Individuals who participated in other clinical studies in the past 3 months. [14]Individuals judged inappropriate for the study by the principal.
Target sample size	12

Research contact person
Name of lead principal investigator	Sumio Kondo
Organization	Medical Corporation Kenshokai, Fukushima Healthcare Center
Division name	Head
Address	2-12-16 Tamagawa Fukushima-ku Osaka-shi Osaka 553-0004, JAPAN
TEL	+81-6-6441-6848
Email	info@tes-h.co.jp

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
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	SHIRATORI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	DRC Co., Ltd.
Name of secondary funｄer(s)

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	2018 Year 09 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 14 Day
Anticipated trial start date	2018 Year 09 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 09 Month 26 Day
Last modified on	2018 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039012