UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000024570
Receipt No. R000028273
Scientific Title A study for the effect of the intake of a plant extracts containing drink on skin conditions and vascular functions.
Date of disclosure of the study information 2016/10/29
Last modified on 2019/07/30 (Ver. 6)

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Basic information
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
Condition Healthy adults
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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)

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 No need to know

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute 701 Research, Inc.
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
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 株式会社セブンオーワンリサーチ（東京都）

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2016 Year 10 Month 26 Day
Last modified on
2019 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028273