UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000057083 |
|---|---|
| Receipt number | R000065184 |
| Scientific Title | Clinical trial on psychological effect by intake of test beverage - A placebo-controlled, single-blind, crossover study - |
| Date of disclosure of the study information | 2026/03/11 |
| Last modified on | 2025/09/10 11:28:32 |
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Basic information
Public title
Clinical trial on psychological effect by intake of test beverage - A placebo-controlled, single-blind, crossover study -
Acronym
Clinical trial on psychological effect by intake of test beverage
Scientific Title
Clinical trial on psychological effect by intake of test beverage - A placebo-controlled, single-blind, crossover study -
Scientific Title:Acronym
Clinical trial on psychological effect by intake of test beverage
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate psychological effects by single intake of test beverage in healthy Japanese males and females 20 years old or older, and under 35 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaires to assess psychological state
Key secondary outcomes
Heart rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake placebo beverage on the day
Interventions/Control_2
Intake test beverage B on the day
Interventions/Control_3
Intake test beverage C on the day
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
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Age: 20 or elder, and less than 35 years
2.Japanese males and females
3.BMI less than 30.0 kg/m^2
4.non-smokers (no history of smoking in the past year)
5. Individuals who have received adequate explanation regarding the trial, can comprehend its contents, and have produced written consent
Key exclusion criteria
1.Currently undergoing medical, pharmacological, or herbal treatment (except for on-demand medicines)
2.Have a history of, or currently have serious cardiac, hepatic, renal, gastrointestinal disease
3.Have a pollen allergy or (seasonal / perennial) allergic rhinitis appeared to cause the symptoms occurrence in the test period
4.Currently receiving diet therapy or physiotherapy under medical supervision
5.Regularly taking commercially available pharmaceuticals, quasi drugs, foods for specified health use (FOSHU), foods with function claims or health food that affect autonomic nervous system, metabolism or sleep, and unable to stop taking during the test period
6. Have any difficulty in measurement using heart rate monitor (e.g. thick body hair on the chest hair, with an implanted pacemaker, etc.)
7. Have sensitive skin around electrode attachment site (chest)
8. Habitual heavy drinkers (daily pure alcohol consumption exceeding 40g)
9. Have significant inconsistency in timing of meals from day to day, or have an irregular sleep cycle (e.g. shift-workers / night shift worker)
10. Participants in other clinical trials currently or within one month before agreeing to participate in this study, or planning to participate in other clinical trials during or within 4 weeks after the test period of this study
11. May have significant stress due to life events such as relocation, job change or separation from close relatives with in 3 months before consent for this study, or planned to have such life events during this study
12. Have difficulty in abstaining from alcohol from the day before the date when study is conducted
13. Have food or drug allergy
14. frequent urination
15. Currently pregnant or breastfeeding, or hoping to get pregnant during the test period
16. Deemed unsuitable for this study by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
HigashiKoganei Sakura Clinic
Division name
Hospital Director
Zip code
184-0011
Address
4-37-26 Higashicho, Koganei-shi, Tokyo, Japan
TEL
042-382-3888
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
ASAHI QUALITY & INNOVATIONS, LTD.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjuku-ku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 11 | 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
| 2025 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 21 | 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 | 02 | Month | 19 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065184
