UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028086 |
|---|---|
| Receipt number | R000032155 |
| Scientific Title | A study for evaluating the effects of oral intake of drink containing plant extract on vascular function. |
| Date of disclosure of the study information | 2017/07/05 |
| Last modified on | 2018/01/09 10:14:50 |
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Basic information
Public title
A study for evaluating the effects of oral intake of drink containing plant extract on vascular function.
Acronym
A study for evaluating the effects of oral intake of drink containing plant extract on vascular function.
Scientific Title
A study for evaluating the effects of oral intake of drink containing plant extract on vascular function.
Scientific Title:Acronym
A study for evaluating the effects of oral intake of drink containing plant extract on vascular function.
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 plant extract on vascular function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of vascular function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
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 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_3
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_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Persons who come under inquiry of cold sensitivity (Terasawa's diagnostic criteria)
Key exclusion criteria
-Persons who have severe allergic disease as rhinitis, atopicdermatitis.
-Patients with vascular function disorder.
-Persons who have problems with electrocardiogram test such as arrhythmia.
-Persons who take medicine.
-Persons who went to hospital regularly to the medical institution within the past one month.
-Persons who had a habit to ingest supplements.
-Current smoker.
-Persons whose systolic blood pressure is over 160mmHg
-Persons who are pregnant or lactating, or plan to become pregnant in the near future.
-Persons who plan to become participates in the other clinical studies or exam.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suma Akane |
Organization
Kao Corporation
Division name
R&D-Skin Care Products Research
Zip code
Address
2-1-3 Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9581
suma.akane@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nakashima Yukinori |
Organization
Kao Corporation
Division name
R&D-Skin Care Products Research
Zip code
Address
2-1-3 Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9581
Homepage URL
nakashima.yukinori@kao.co.jp
Sponsor or person
Institute
Kao Corporation
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
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 | 07 | Month | 05 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 05 | 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
| 2017 | Year | 07 | Month | 05 | Day |
Last modified on
| 2018 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032155
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
