UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035043
Receipt number R000039953
Scientific Title 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 2019/12/24 18:45:38

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Basic information

Public title

Study for the effect of intake of test drink on skin
SWE-2018-05-HD1101

Acronym

Study for the effect of intake of test drink on skin

Scientific Title

Study for the effect of intake of test drink on skin
SWE-2018-05-HD1101

Scientific Title:Acronym

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

1st name
Middle name
Last name Takao Tanaka

Organization

SUNTORY WELLNESS LIMITED

Division name

Institute for Health Care Science

Zip code


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

1st name
Middle name
Last name Wakana Taguchi

Organization

SUNTORY WELLNESS LIMITED

Division name

Institute for Health Care Science

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-6122

Homepage URL


Email

Wakana_Taguchi@suntory.co.jp


Sponsor or person

Institute

SUNTORY WELLNESS LIMITED

Institute

Department

Personal name



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)



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 12 Month 02 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 11 Month 15 Day

Date of IRB

2018 Year 11 Month 15 Day

Anticipated trial start date

2018 Year 12 Month 02 Day

Last follow-up date

2019 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 11 Month 28 Day

Last modified on

2019 Year 12 Month 24 Day



Link to view the page

Value
https://center6.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