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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035043
Receipt No. R000039953
Official scientific title of the study Study for the effect of intake of test drink on skin SWE-2018-05-HD1101
Date of disclosure of the study information 2018/12/02
Last modified on 2018/11/28

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Basic information
Official scientific title of the study Study for the effect of intake of test drink on skin
SWE-2018-05-HD1101
Title of the study (Brief title) Study for the effect of intake of test drink on skin
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of drink intake on skin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of skin condition (screening, Week 0, Week 4, Week 8, Week 12)
Key secondary outcomes questionnaire (screening, Week 0, Week 4, Week 8, Week 12)

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Drink containing food ingredients, 12 Weeks
Interventions/Control_2 Drink not containing food ingredients, 12 Weeks
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
40 years-old <=
Age-upper limit
65 years-old >
Gender Female
Key inclusion criteria (1)Women aged 40 to 64 years at the time of acquisition of agreement in participating in this study.
(2)Those who can visit the specified institution on the scheduled day of visit
(3)Those who adequately understand the objective and details of this study, and give written informed consent
Key exclusion criteria (1)Subjects who are or are possibly pregnant, or are lactating.
(2)Subjects who are;
a)With present heart disorder, liver disorder, or kidney disorder,
b)With history of cardiac disorder,
c)With diabetes mellitus, or
d)With allergy to the study foods.
(3)Subjects who are with treatment
(4)Subjects who are with skin disease, such as atopic dermatitis.
(5)Subjects who are with strange skin conditions at measurement points.
(6)Subjects who cannot avoid daylight exposure (such as sunbathing, tanning machine) during the test period.
(7)Subjects who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements claiming to improve skin condition the past 3 months or will ingest those foods during the test period.
(8)Subjects who had been conducted an operation on the test spot in the past 1 year.
(9)Subjects who have a habit to use drug claiming to improve skin condition in the past 3 months.
(10)Subjects judged inappropriate for the study by the principal.
Target sample size 90

Research contact person
Name of lead principal investigator Takao Tanaka
Organization SUNTORY WELLNESS LIMITED
Division name Institute for Health Care Science
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0590
Email Takao_Tanaka@suntory.co.jp

Public contact
Name of contact person Wakana Taguchi
Organization SUNTORY WELLNESS LIMITED
Division name Institute for Health Care Science
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-6122
Homepage URL
Email Wakana_Taguchi@suntory.co.jp

Sponsor
Institute SUNTORY WELLNESS LIMITED
Institute
Department

Funding Source
Organization SUNTORY WELLNESS LIMITED
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 12 Month 02 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 15 Day
Anticipated trial start date
2018 Year 12 Month 02 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 11 Month 28 Day
Last modified on
2018 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039953

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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