UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020896 |
|---|---|
| Receipt number | R000024109 |
| Scientific Title | Study of the effects of beverage containing plant ingredient on mental stress. |
| Date of disclosure of the study information | 2016/02/05 |
| Last modified on | 2019/02/07 09:15:26 |
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Basic information
Public title
Study of the effects of beverage containing plant ingredient on mental stress.
Acronym
Study of the effects of beverage containing plant ingredient on mental stress.
Scientific Title
Study of the effects of beverage containing plant ingredient on mental stress.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kohei Marumo |
Organization
Hongo-Todaimae kokorono Clinic
Division name
Director
Zip code
Address
3F Kaneyasu building, 2-40-11 ,Hongo, Bunkyo-ku, Tokyo,
TEL
03-6801-8115
maruko1192@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Tamura |
Organization
TES Holdings Co., Ltd
Division name
Department of Clinical Trial
Zip code
Address
6F University of Tokyo Entrepreneur Plaza, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-6801-8480
Homepage URL
t.tamura@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 12 | Month | 14 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024109
