UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052510 |
|---|---|
| Receipt number | R000059924 |
| Scientific Title | An observation study for the relationship between drink contains functional ingredients and health check. |
| Date of disclosure of the study information | 2023/10/18 |
| Last modified on | 2024/01/17 14:10:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An observation study for the relationship between drink contains functional ingredients and health check.
Acronym
An observation study for the relationship between drink contains functional ingredients and health check.
Scientific Title
An observation study for the relationship between drink contains functional ingredients and health check.
Scientific Title:Acronym
An observation study for the relationship between drink contains functional ingredients and health check.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the relationship between various lifestyle and health indicators.
Basic objectives2
Others
Basic objectives -Others
-
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health check value and various lifestyle
Key secondary outcomes
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adults who are at least 20 years old at the time of consent and less than 65 years old at the end of the study.
(2) Subjects who can make self-judgment and voluntarily gave informed consent.
Key exclusion criteria
(1) Subjects who were hospitalized, pregnant, gave birth, or took long-term medication from 2021 to 2023.
(2) Subjects who did not have the following health examination data in 2022 and 2023.
(3) Subjects who consume health drinks or supplements that affect the examination at least twice a week.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Minami |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-3182-6161
Hisako_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Sato |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
05031820954
Homepage URL
Mariko_Sato@suntory.co.jp
Sponsor or person
Institute
Mibyou Life Sicence Inc.
Institute
Department
Personal name
Funding Source
Organization
Suntory beverage & Food limited.
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
| 2023 | Year | 10 | Month | 18 | 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
| 2023 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059924
