UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024570 |
|---|---|
| Receipt number | 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 18:42:41 |
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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
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
701@above-ac.com
Sponsor or person
Institute
701 Research, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028273
