UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effects of oral intake of drink containing plant extract on vascular function.
Title of the study (Brief title)	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	Suma Akane
Organization	Kao Corporation
Division name	R&D-Skin Care Products Research
Address	2-1-3 Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL	+81-3-5630-9581
Email	suma.akane@kao.co.jp

Public contact
Name of contact person	Nakashima Yukinori
Organization	Kao Corporation
Division name	R&D-Skin Care Products Research
Address	2-1-3 Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL	+81-3-5630-9581
Homepage URL
Email	nakashima.yukinori@kao.co.jp

Sponsor
Institute	Kao Corporation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032155