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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035797
Receipt No. R000040775
Official scientific title of the study A study for the skin moisturizing effect of a beverage intake on in adult female who are aware of skin dryness (Preliminary test)
Date of disclosure of the study information 2019/02/07
Last modified on 2019/02/12

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Basic information
Official scientific title of the study A study for the skin moisturizing effect of a beverage intake on in adult female who are aware of skin dryness (Preliminary test)
Title of the study (Brief title) A study for the skin moisturizing effect of a beverage intake
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and skin moisturizing effect of intake of test food for 8 weeks
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stratum corneum water content
Key secondary outcomes Transepidermal water loss
VISIA

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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of 2 test foods per day for 8 consecutive 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
64 years-old >=
Gender Female
Key inclusion criteria 1.Healthy females from 20 to 64 years of age
2.Subjects who are aware of skin dryness and lower level of Stratum corneum water content
Key exclusion criteria Subjects
1.who usually drink hard water or mineral water
2.who usually take some foods, drugs, functional foods, etc. which would affect skin condition
3.who got some cosmetic surgery which would affect the target skins
4.who got some cosmetic surgery, or hormone therapy which would affect the Other than target skins within 1 year before the screening test
5.who got esthetic treatments would affect the target skins within 1 month before the screening test, or plan the act
6.who plan to have ultraviolet exposure within 1 month before the screening test
7.who wash the body using a nylon towel, etc. which provides strong skin irritation
8.who usually use bath additives
9.who have the wounds or inflammatory diseases which would affect the target skins
10.who might have symptom of pollinosis during between February to April in the past 3 years or who are expected to have allergic symptoms on the skin during this study
11.who feel skin roughness on the target skin around a menstruates
12.who employ on a pre-dawn shift or on night duty more than 2 times in this study
13.who are planning to go overseas
14.who have asthma or would have asthma during this study
15.who have or has medical history serious disease
16.who have allergic reaction related to this study or who cannot ingest carbonated beverages
17.who have disease under treatment or who have serious disease medical history requiring medication treatment affecting this study
18.who are judged inappropriate for the study according to the results of screening test
19.who have participated in other clinical studies within 1 month, or are planning to participate in other clinical studies during this study
20.who are pregnant or lactating, or plan to become pregnant or lactate during this study
21.who are judged as unsuitable due to lifestyle questionnaire
22.who are judged as unsuitable for the study by investigator for other reasons
Target sample size 10

Research contact person
Name of lead principal investigator Yasumasa Sugiura
Organization Georgia Premium Foods
Division name -
Address 3-6-9, Shiba Minato-ku, Tokyo
TEL 03-6275-1023
Email sugiura@nabeghlavi.co.jp

Public contact
Name of contact person Kyohei Hashimoto
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email k.hashimoto@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization Georgia Premium Foods
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2019 Year 02 Month 07 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2019 Year 01 Month 25 Day
Anticipated trial start date
2019 Year 02 Month 08 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
2019 Year 02 Month 07 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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