UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048755 |
|---|---|
| Receipt number | R000055546 |
| Scientific Title | Evaluating the Mental Status of the Effects of Specific Beverage Interventions on Humans |
| Date of disclosure of the study information | 2022/08/25 |
| Last modified on | 2022/11/15 18:53:01 |
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Basic information
Public title
Evaluating the Mental Status of the Effects of Specific Beverage Interventions on Humans
Acronym
Evaluating the Mental Status of the Effects of Specific Beverage Interventions on Humans
Scientific Title
Evaluating the Mental Status of the Effects of Specific Beverage Interventions on Humans
Scientific Title:Acronym
Evaluating the Mental Status of the Effects of Specific Beverage Interventions on Humans
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate mental state before and after ingestion of the beverage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mental state questionnaire
(Likert scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A single 50ml intake of test drink 1
Interventions/Control_2
A single 50ml intake of test drink 2
Interventions/Control_3
A single 50ml intake of test drink 3
Interventions/Control_4
A single 50ml intake of test drink 4
Interventions/Control_5
A single 50ml intake of test drink 5
Interventions/Control_6
A single 50ml intake of placebo drink
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women aged between 20 and 65 at the time of informed consent.
2.Those who can visit the designated office and fill in the records
3.No stuffy nose
4.Able to distinguish scent
5.Those who have received a sufficient explanation of the purpose and content of the study and have given written consent to participate voluntarily.
Key exclusion criteria
1.Those who don't like the smell of coffee
2.Those who have or are aware of an olfactory impairment
3.Those with symptoms of rhinitis
4.Those suffering from serious illness
5.Those who are pregnant or breastfeeding
6.Irregular lifestyle
7.hose who have participated in other clinical trials or clinical trials within the last month
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | soichi |
| Middle name | |
| Last name | yoneda |
Organization
Mibyou Life Science inc
Division name
Clinical Trials Division
Zip code
1010061
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
TEL
03-6256-9600
renraku@mibyou-ls.com
Public contact
Name of contact person
| 1st name | soichi |
| Middle name | |
| Last name | yoneda |
Organization
Mibyou Life Science inc
Division name
Clinical Trials Division
Zip code
1010061
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
TEL
03-6256-9600
Homepage URL
renraku@mibyou-ls.com
Sponsor or person
Institute
Mibyou Life Science inc
Institute
Department
Personal name
Funding Source
Organization
Mibyou Life Science inc
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
Mibyou Research Ethics Review Committee
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
Tel
03-6272-9163
renraku@npo-mibyou.com
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
| 2022 | Year | 08 | Month | 25 | 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
| 2022 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 25 | Day |
Last modified on
| 2022 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055546
