UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024478
Receipt number R000028173
Scientific Title The exploratory study of plant polyphenols for the effect to skin.
Date of disclosure of the study information 2016/10/26
Last modified on 2016/10/19 11:44:37

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Basic information

Public title

The exploratory study of plant polyphenols for the effect to skin.

Acronym

The exploratory study of plant polyphenols for the effect to skin.

Scientific Title

The exploratory study of plant polyphenols for the effect to skin.

Scientific Title:Acronym

The exploratory study of plant polyphenols for the effect to skin.

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To explore the effect to skin of plant polyphenols.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skin condition score 4, 8, 12 weeks after intervention

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Subjects will take the food containing plant polyphenols for 12 weeks.

Interventions/Control_2

Subjects will take the food not containing plant polyphenols for 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

30 years-old <=

Age-upper limit

60 years-old >

Gender

Female

Key inclusion criteria

1) 30 years of age or older, and less than 60 years of age.
2) Subjects who care about skin.

Key exclusion criteria

1)Use of medicines for skin treatment.
2)Subjects with atopic dermatitis
3)Subjects with abnormality on the face skin.
4)Subjects with serious disease
5)Subjects in pregnancy, lactation and scheduled pregnancy period.
6)Investigator's judgment for other reason

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuhiro Zeida

Organization

Suntory Global Innovation Center LTD.

Division name

Research Institute

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284

TEL

050-3182-0464

Email

Mitsuhiro_Zeida@suntory.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuko Fukui

Organization

Suntory Global Innovation Center LTD.

Division name

Research Institute

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284

TEL

050-3182-0456

Homepage URL


Email

Yuko_Fukui@suntory.co.jp


Sponsor or person

Institute

Suntory Global Innovation Center LTD.

Institute

Department

Personal name



Funding Source

Organization

None

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

2016 Year 10 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

Preinitiation

Date of protocol fixation

2016 Year 09 Month 28 Day

Date of IRB


Anticipated trial start date

2016 Year 10 Month 26 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

2016 Year 10 Month 19 Day

Last modified on

2016 Year 10 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028173


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name