UMIN-CTR Clinical Trial

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

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

SHIRATORI Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

DRC Co., Ltd.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

09

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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