UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of continuous ingestion of drink containing plant extract. N-18003
Title of the study (Brief title)	Examination of continuous ingestion of drink containing plant extract. N-18003
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 and autonomic nerve activity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin temperature.
Key secondary outcomes	Peripheral blood flow, subjective evaluation and autonomic nerve activity.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Continuous ingestion of drink containing plant extract
Interventions/Control_2	Continuous ingestion of placebo drink not containing plant extract
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	20 years-old <=
Age-upper limit	30 years-old >=
Gender	Female
Key inclusion criteria	1.Healthy adults 2.Person who agrees not to ingest specified foods and supplements during the test period.
Key exclusion criteria	1.Person whose diastolic blood pressures are more than 90mmHg and systolic ones are more than 140mmHg. 2.Person who has severe allergic disease as rhinitis, atopicdermatitis. 3.Person who is pregnant, lactating or planned to become pregnant during the test period. 4.Patient with vascular function disorder. 5.Person who has problems with electrocardiogram test such as arrhythmia. 6.Person who takes medicine. 7.Person who regularly goes to hospital or went to the medical institution within a month. 8.Current smoker. 9.Person who plans to participate in the other clinical studies. 10.Person who is judged as unsuitable for the study by the investigator for other reasons.
Target sample size	12

Research contact person
Name of lead principal investigator	Yamamoto Noriyuki
Organization	Japanese Red Cross Hokkaido College of Nursing
Division name	Department of Health Sciences, Professor
Address	1-664 Akebono Kitami Hokkaido
TEL	+81-157-66-3390
Email	yama@rchokkaido-cn.ac.jp

Public contact
Name of contact person	Yukinori Nakashima
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.com

Sponsor
Institute	Japanese Red Cross Hokkaido College of Nursing
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（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 23 Day
Anticipated trial start date	2018 Year 03 Month 12 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	2018 Year 03 Month 05 Day
Last modified on	2018 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036068