UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056013 |
|---|---|
| Receipt number | R000064010 |
| Scientific Title | Observational Study on the Relationship Between Daily Mood, Biomarkers, and Beverage Intake |
| Date of disclosure of the study information | 2024/11/04 |
| Last modified on | 2024/11/11 10:40:05 |
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Basic information
Public title
Observational Study on the Relationship Between Daily Mood, Biomarkers, and Beverage Intake
Acronym
Observational Study on the Relationship Between Daily Mood, Biomarkers, and Beverage Intake
Scientific Title
Observational Study on the Relationship Between Daily Mood, Biomarkers, and Beverage Intake
Scientific Title:Acronym
Observational Study on the Relationship Between Daily Mood, Biomarkers, and Beverage Intake
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of beverage intake on human mood and biomarkers, a study will be conducted on the relationship between daily mood, biomarkers, and beverage intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological evaluation questionnaire
Key secondary outcomes
1. Physiological measurements using a wearable device
2. Beverage-related questionnaire
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Aged 20 to under 40 at the time of informed consent.
(2)Japanese male and female
(3)BMI of less than 30.0 kg/m2
(4)Those who does not smoke (who have not been smoking for the last year)
(5)Those who frequently purchase beverages in daily life.
(6)Those who are using an iPhone with iOS 16 or late.
(7)Those who have received a thorough explanation of the purpose and content of this study, have the capacity to consent, fully understand the content, and can provide their consent through electronic informed consent.
Key exclusion criteria
(1)Taking medication or Chinese medication (except for the dugs as needed)
(2)Current of history of serious diseases such as heart, liver, kidney, gastrointestinal tract.
(3)Those who has pollinosis (autumn pollen) or allergic rhinitis (seasonal/perennial)
(4)Under diet of exercise therapy under the supervision of a doctor
(5)Those who regularly uses any commercially available drug and quasi-drug, food for specified health use, food that affects autonomic nervous system, and sleep (however, the person will be eligible if he/she can stop using it during the study period after provision of the informed consent)
(6)Excessive consumption of alcohol (alcohol equivalent 60g or more /day)
(7)Irregular diet, shift worker, night shift, irregular life rhythm
(8)Those who has participated another clinical study within 1 month prior to provision of the informed consent , other than the psychological evaluation study conducted by AQI,or is currently participating in it, or will participate in it during the study period or within 4 weeks after the end of the study
(9)Those who will be possibly under significant stress of any life event such as moving, changing his/her job, and separation from a close relative, within 3 months prior to provision of the informed consent, or will have such a life event during the study period
(10)Current of history of drug and/or food allergies
(11)Those who is unable to drink alcohol constitutionally
(12)Those who are breastfeeding, pregnant, possibly pregnant, or intend to become pregnant during the study period.
(13)Those who have difficulty wearing a wristwatch-type wearable device on a daily basis.
(14)Judged by the investigator to be unsuitable for participating in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinnya |
| Middle name | |
| Last name | Oikawa |
Organization
Medical Corporation asociations Shokoukai Comfo-Garden Clinic
Division name
Chairman
Zip code
162-0054
Address
Kawada-Cho3-2, Shinjyuku-ku, Tokyo
TEL
03-5368-6980
comfo-rinshou@synaps.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
080-5186-5400
Homepage URL
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, Ltd
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukiji Futaba Clinic Ethics Review Committee.
Address
Tsukiji 1-9-9, Chuou-ku, Tokyo
Tel
03-6226-5812
info@hikobae.net
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
| 2024 | Year | 11 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2024 | Year | 11 | Month | 01 | Day |
Last modified on
| 2024 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064010
