UMIN-CTR Clinical Trial

Public title

A study for the effect of the intake of a plant extracts containing drink on skin conditions and vascular functions.

Acronym

A study for the effect of the intake of a plant extracts containing drink on skin conditions and vascular functions.

Scientific Title

A study for the effect of the intake of a plant extracts containing drink on skin conditions and vascular functions.

Scientific Title:Acronym

A study for the effect of the intake of a plant extracts containing drink on skin conditions and vascular functions.

Region

Japan

Condition

Healthy adults

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to evaluate the effects of intake of the plant extract containing drink on skin conditions and vascular function.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Measurement of skin condition
(measurement time: 0,4,8weeks after ingestion of the test drink)

Key secondary outcomes

Observation of skin texture
Measurement of vascular function
(measurement time: 0,4,8weeks after ingestion of the test drink)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of a bottle of placebo drink once a day for 8 weeks.

Interventions/Control_2

Ingestion of a bottle of test drink once a day for 8 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

Age-lower limit

25

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Female

Key inclusion criteria

1. Healthy female aged from 25 to 59 years old
2. Persons who have felt mental stress and fatigue.
3. Persons who have dry skin.
4. Menstrual cycle is stable.
5. BMI is from 18.5 to 25.0
6. Person who drink to two cups of coffee per day.

Key exclusion criteria

1. Persons who are outpatients or were treated by doctor recently.
2. Persons who are pregnant or lactating, or planned to become pregnant in the near future.
3. Persons who have problems with electrocardiogram test such as arrhythmia.
4. Persons who take medicine (example: sleeping pills, anti-allergic drugs, hormone drugs, laxative, antiflatulent, and other medicines)
5. Persons who routinely take quasi-drugs and healthy foods.
6. Persons who have severe allergic disease as pollen allergy, rhinitis, atopic dermatitis.
7. Persons who have possibilities for emerging allergy to foods and cosmetics.
8. Current smoker
9. Persons who have received a cosmetic medicine (cosmetic surgery, injection of collagen, laser treatment, etc.)
10. Persons whose blood pressure is 140mmHg or more.
11. Persons who are participate in the other clinical studies
12. Patients with vascular function disorder.
13. Persons who are judged as unsuitable for the study by the investigator for other reason.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Shoichiro Yano, M.D.

Organization

Yaesu Nihonbashi Skin Clinic

Division name

Director

Zip code

Address

Yaesu Kagawa Building 3F, 1-5-17 Yaesu, Chuo-ku, Tokyo

TEL

03-6202-1200

Email

yanosyo-tky@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Ritsuko Cardona

Organization

701 Research, Inc.

Division name

Manager

Zip code

Address

Grand Maison Sendagi Ichiban-kan 2F, 4-1-16, Sendagi Bunkyo-ku, Tokyo 113-0022 Japan

TEL

03-5832-9875

Homepage URL

Email

701@above-ac.com

Institute

701 Research, Inc.

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

株式会社セブンオーワンリサーチ（東京都）

Date of disclosure of the study information

2016

Year

10

Month

29

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

108

Results

Results: After ingesting coffee polyphenols (CPPs), including chlorogenic acids, for 8 weeks, the water holding capacity levels increased on the measured areas of the body. In addition, the increase in transepidermal water loss levels after tape-stripping was suppressed. Furthermore, an improvement of subjective stress symptoms was observed.

Results date posted

2019

Year

07

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2017

Year

10

Month

20

Day

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

10

Month

08

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

30

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

10

Month

26

Day

Last modified on

2019

Year

07

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028273