UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059582 |
|---|---|
| Receipt number | R000068150 |
| Scientific Title | Effects of a research beverage on water Intake in healthy subjects |
| Date of disclosure of the study information | 2025/11/02 |
| Last modified on | 2025/10/29 18:41:23 |
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Basic information
Public title
Effects of a research beverage on water Intake in healthy subjects
Acronym
Effects of a research beverage on water Intake in healthy subjects
Scientific Title
Effects of a research beverage on water Intake in healthy subjects
Scientific Title:Acronym
Effects of a research beverage on water Intake in healthy subjects
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effects of consuming the research food on daily fluid intake, using the control food as a reference
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Water intake (from research food)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the research food outside of scheduled meals and beverage intake times
Interventions/Control_2
Consumption of the control food outside of scheduled meals and beverage intake times
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 59 years of age
(2) Subjects weighing 45 to 65 kg (priority given to those weighing 50 to 60 kg)
(3) Subjects who have no aversion to the taste of research food and can consume it without any issues
(4) Subjects who can finish a set meal
(5) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Key exclusion criteria
(1) Subjects who consciously adjust their beverage intake daily (including those who are restricted from consuming beverages due to illness)
(2) Subjects who have excessive exercise habits
(3) Subjects who have a smoking habit
(4) Subjects who consume alcohol on a regular basis (Alcohol equivalent of 40 g or more per day)
(5) Subjects who have a disease that requires constant medication (whether external or internal), those who have a disease under treatment (except for dry eye and dental caries treatment), those who have a history of serious disease that required medication, and those who are scheduled for surgery
(6) Subjects who have dietary restrictions due to heart disease, liver disease, digestive disorders, kidney disease, diabetes, or other illnesses
(7) Subjects who have a scheduled menstruation during the study period (Intake Phase I and II)
(8) Subjects who work in shifts, work late at night, and have an irregular daily rhythm
(9) Subjects who have participated in other clinical studies, trials, or human studies within one month prior to the start of this study
(10) Subjects who plan to become pregnant or breastfeed during the study period
(11) Subjects who are judged to be unsuitable as a subject based on the results of the preliminary examination
(12) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey
(13) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Oki |
Organization
Medical Corporation Seishukai Seishukai Clinic
Division name
Clinical trial office
Zip code
111-0036
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
TEL
03-5827-0930
m-oki@seishukai.or.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Yamamoto |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo,
TEL
070-3023-8214
Homepage URL
yamamoto.keiji799@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.co.jp
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
医療法人社団成守会 成守会クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 02 | 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
| 2025 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068150
