UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029931 |
|---|---|
| Receipt number | R000034189 |
| Scientific Title | Examination of single ingestion of drink containing plant extract. N-17003 |
| Date of disclosure of the study information | 2017/11/13 |
| Last modified on | 2020/04/27 10:14:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of single ingestion of drink containing plant extract.
N-17003
Acronym
Examination of single ingestion of drink containing plant extract.
N-17003
Scientific Title
Examination of single ingestion of drink containing plant extract.
N-17003
Scientific Title:Acronym
Examination of single ingestion of drink containing plant extract.
N-17003
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of single ingestion of drink containing plant extract on skin temperature.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin temperature.
Key secondary outcomes
Subjective evaluation.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Drink containing plant extract in high concentration (single ingestion)->washout period->drink containing plant extract in low concentration (single ingestion)->washout period->placebo drink not containing plant extract (single ingestion)
Interventions/Control_2
Drink containing plant extract in high concentration (single ingestion)->washout period->placebo drink not containing plant extract (single ingestion) ->washout period-> drink containing plant extract in low concentration (single ingestion)
Interventions/Control_3
Drink containing plant extract in low concentration (single ingestion)->washout period->placebo drink not containing plant extract (single ingestion) ->washout period->drink containing plant extract in high concentration (single ingestion)
Interventions/Control_4
Drink containing plant extract in low concentration (single ingestion)->washout period->drink containing plant extract in high concentration (single ingestion) ->washout period->placebo drink not containing plant extract (single ingestion)
Interventions/Control_5
Placebo drink not containing plant extract (single ingestion) ->washout period->drink containing plant extract in high concentration (single ingestion) ->washout period->drink containing plant extract in low concentration (single ingestion)
Interventions/Control_6
Placebo drink not containing plant extract (single ingestion)->washout period->drink containing plant extract in low concentration (single ingestion) ->washout period->drink containing plant extract in high concentration (single ingestion)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Healthy adults
2.Person whose body math indexes are from 18.5 or more to 25 less than 25.0
3.Person whose diastolic blood pressures are less than 90mmHg and systolic ones less than 140mmHg.
4.Person who are sensitive to cold.
5.Person who can agree not to ingest specified foods and supplements during the test period.
Key exclusion criteria
1.Persons who have severe allergic disease as rhinitis, atopicdermatitis.
2.Patients with vascular function disorder.
3.Persons who have problems with electrocardiogram test such as arrhythmia.
4.Persons who take medicine.
5.Persons who went to hospital regularly to the medical institution within the past one month.
6.Current smoker .
7.Persons who plan to become participates in the other clinical studies or exam.
8.Person who is judged as unsuitable for the study by the investigator for other reasons.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Akane |
| Middle name | |
| Last name | Suma |
Organization
Kao Corporation
Division name
R&D-Skin Care Products Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9581
suma.akane@kao.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd
Division name
Administrative Department of Clinical Trials
Zip code
113-0033
Address
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
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
Human Research Ethics Committee, Kao corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-9220
uesaka.toshio@kao.co.jp
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
花王株式会社ソフトリサーチセンター（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
http://lifescience.co.jp/yk/index.html
Publication of results
Published
Result
URL related to results and publications
http://lifescience.co.jp/yk/index.html
Number of participants that the trial has enrolled
24
Results
A cold stress was performed on both hands of each subject after ingesting a beverage containing chlorogenic acid (CGA). Recovery of skin temperature (SkT) were measured before and after the cold stress. Significant improvement of the recovery of SkT after the cold stress test were observed in CGA compared with placebo.
Results date posted
| 2020 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 03 | Month | 30 | Day |
Baseline Characteristics
Healthy adult males
Participant flow
Drink (single ingestion)>washout period>drink(single ingestion))>washout period>drink(single ingestion)
Adverse events
None
Outcome measures
Skin temperature and subjective evaluation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 11 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034189
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
