UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059324 |
|---|---|
| Receipt number | R000067843 |
| Scientific Title | Clinical study on the effects of the test beverage on heart rate - a randomized, placebo-controlled, double-blind, 2-period crossover trial - |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/04/03 12:50:39 |
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Basic information
Public title
Clinical study on the effects of the test beverage on heart rate
- a randomized, placebo-controlled, double-blind, 2-period crossover trial -
Acronym
Clinical study on the effects of the test beverage on heart rate
Scientific Title
Clinical study on the effects of the test beverage on heart rate
- a randomized, placebo-controlled, double-blind, 2-period crossover trial -
Scientific Title:Acronym
Clinical study on the effects of the test beverage on heart rate
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to objectively assess the impact of a single intake of the test beverage on heart rate in healthy men and women aged 20 to under 40.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate
Key secondary outcomes
Psychological assessment questionnaire
Cognitive function evaluation (Cognitrax)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
Participants will consume 200 mL of the test beverage (at room temperature) over 5 minutes while seated at rest.
Interventions/Control_2
Participants will consume 200 mL of the placebo beverage (at room temperature) over 5 minutes while seated at rest.
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. Age: 20 to under 40 years
2. Sex: Japanese men and women
3. BMI less than 30.0 kg/m^2
4. Non-smokers (no smoking in the past year)
5. Provided written informed consent after receiving sufficient explanation and understanding purpose and procedures of the study
Key exclusion criteria
1. Currently receiving treatment or medicine (including herbal treatment) for any illness (as-needed use permitted)
2. Have a history of or currently have serious disease of the heart, liver, kidneys, or digestive system
3. Hay fever or allergic rhinitis (seasonal or perennial); those without symptoms during the study period may participate
4. Under dietary or exercise therapy supervised by a physician
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 them during the test period
6. Difficulty in proper heart rate measurement or device attachment
7. Prone to skin irritation at electrode sites (chest)
8. Difficulty in proper smartwatch measurement (e.g., thick arm hair)
9. Heavy alcohol consumption (>=40 g/day)
10. Excessive daily caffeine intake (>=400 mg/day)
11. Extremely irregular eating habits or irregular lifestyle due to shift work or night shifts
12. Participation in another clinical study currently or within one month before agreeing to participate in this study, or planning to participate in another clinical study during or within 4 weeks after the test period of this study
13. Major life stress events (e.g., moving, job change, bereavement) within 3 months before consent or expected during the study
14. Unable to abstain from alcohol from the day before the study
15. Allergies to medications or foods
16. Frequent urination
17. Pregnant, breastfeeding, or planning pregnancy during the study
18. 18. Unable to consume caffeine due to constitution
19. Deemed unsuitable for participation 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
Higashi Koganei 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 | 10 | Month | 15 | 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 | 09 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 26 | 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 | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067843
