UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034272
Receipt number R000039012
Scientific Title Examination of the Effects and Safety of Applying and Ingesting Test Products on Sliming and Blood Flow.
Date of disclosure of the study information 2018/09/26
Last modified on 2018/12/04 10:43:40

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Basic information

Public title

Examination of the Effects and Safety of Applying and Ingesting Test Products on Sliming and Blood Flow.

Acronym

Examination of the Effects and Safety of Applying and Ingesting Test Products on Sliming and Blood Flow.

Scientific Title

Examination of the Effects and Safety of Applying and Ingesting Test Products on Sliming and Blood Flow.

Scientific Title:Acronym

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

1st name
Middle name
Last name Sumio Kondo

Organization

Medical Corporation Kenshokai, Fukushima Healthcare Center

Division name

Head

Zip code


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

1st name
Middle name
Last name Ryoma Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code


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 or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2018 Year 09 Month 14 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039012


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name