UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the effects of beverage containing plant ingredient on mental stress.
Title of the study (Brief title)	Study of the effects of beverage containing plant ingredient on mental stress.
Region	Japan

Condition
Condition	No (subjects with high sensitivity for mental stress)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of beverage containing plant ingredient on reducing mental stress.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Saliva mental stress markers
Key secondary outcomes	Saliva mental stress marker Questionnaires of mental stress

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Beverage containing plant ingredient, single daily drinking.
Interventions/Control_2	Placebo beverage not containing plant ingredient, single daily drinking.
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Individuals aged from 20 to 50 years, when giving the informed consent. (2)Healthy individuals with no chronic disease (3)Individuals who feel the mental stress, or tension, blush, heart rate goes up, when speak in front of people. (4)Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will. (5)Individuals who can accomplish their tasks in the study at the appointed date (6)Individuals who are judged suitable for this study by the investigator.
Key exclusion criteria	Individuals who are under treatment of some disease or who always use drug or quasi-drug other than disease treatment purposes Individuals who are, or are under treatment or have a history of serious disease or/and thyroid gland disease, adrenal gland disease, and/or metabolic disorder Individuals who are under treatment related to psychological stress or/and who are using related pharmaceutical products, supplements, health food Individuals who are taking anti histamine drugs Individuals who are xerostomia, or have subjective symptom of xerostomia Individuals who have under treatment or history of drug addiction and/or alcoholism Systolic and diastolic blood pressures are over 160 mmHg and 100 mmHg Individuals who have drug allergy, food allergy and/or possibility of allergy symptoms onset Individuals who have subjective symptoms of anemia Individuals who are predicted or occurred to have life events, which may have huge effects on mental conditions Individuals who are/were profession to speak, or sales positions Individuals who are smoker Individuals who can not stop drinking alcohol during the day before, and end of each test of each inspection day, or who can not stop to intake caffeine containing foods or beverages from morning until the end of test in each inspection day, or who can not have night sleep because of shift work or other reasons Workers who have holiday between weekdays Individuals who do not wake up between AM6:00 and AM9:00 Individuals who and whose family work for a company manufacturing or selling healthy foods or functional foods Individuals who are planned to participate in other clinical study during this study periods, or who are planned to become pregnant during the current study or are pregnant or lactating Individuals who have significantly deviated value of body measurement Individuals who are judged as unsuitable for the study by the background investigation Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	50

Research contact person
Name of lead principal investigator	Kohei Marumo
Organization	Hongo-Todaimae kokorono Clinic
Division name	Director
Address	3F Kaneyasu building, 2-40-11 ,Hongo, Bunkyo-ku, Tokyo,
TEL	03-6801-8115
Email	maruko1192@gmail.com

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd
Division name	Department of Clinical Trial
Address	6F University of Tokyo Entrepreneur Plaza, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-6801-8480
Homepage URL
Email	t.tamura@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization	Kirin Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kurume University
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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 14 Day
Anticipated trial start date	2016 Year 02 Month 08 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 05 Day
Last modified on	2019 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024109