UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055834 |
|---|---|
| Receipt number | R000063782 |
| Scientific Title | A study to evaluate how the intake of the test beverage effects on English learning behavior |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2026/01/13 09:27:43 |
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Basic information
Public title
A study to evaluate how the intake of the test beverage effects on English learning behavior
Acronym
A study to evaluate how the intake of the test beverage effects on English learning behavior
Scientific Title
A study to evaluate how the intake of the test beverage effects on English learning behavior
Scientific Title:Acronym
A study to evaluate how the intake of the test beverage effects on English learning behavior
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the English learning behavior effects on ingesting the test beverage on Japanese males and females aged 20 to 35.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of Learning Activities
Key secondary outcomes
(Secondary outcomes)
Psychological questionnaire, Questionnaire on English Learning
(Safety evaluation)
Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Learning English (2 weeks) - Intake the test beverage once a day before and during English study (2 weeks)
Interventions/Control_2
Learning English (2 weeks) - Learning English (2 weeks)
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Japanese males and females aged between 20 and 35 years old at the time of obtaining written consent.
2.Subjects who have high motivation to learn English and are willing to learn English using an application "Study Sapuri"
3.Subjects who can study at least 4 days per week (about 30 minutes per day) during the study period.
4.Subjects who do not reject the flavor of the test beverage.
5.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Key exclusion criteria
1.Subjects receiving medication or outpatient treatment for a serious disease.
2.Subjects with current or previous history of drug dependence or alcohol dependence.
3.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder.
4.Subjects whose eating, sleeping, and other habits are extremely irregular.
5.Subjects who have an irregular lifestyle due to night shift work, etc.
6.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more) or excessive smokers (21 cigarettes/day or more).
7.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases.
8.Subjects who participated in another clinical study/research within 1 months before the date of informed consent or who plan to participate in another clinical study/research during the study period.
9.Females who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period.
10.Subjects who are scheduled to learn English other than the intervention for this study during the study period and cannot cancel the schedule.
11.Subjects who have experience in learning English using "Study Sapuri".
12.Subjects who have difficulty complying with recording of each survey form.
13.Subjects whose various test results at screening indicate their ineligibility to participate in the study.
14.Other Subjects who are considered ineligible for participation in the study by the investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bld 5F, 4-11-17 Shibaura, Minato-ku, Tokyo Japan
TEL
03-3431-1260
rd@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bld 5F, 4-11-17 Shibaura, Minato-ku, Tokyo Japan
TEL
03-3431-1260
Homepage URL
rd@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
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
Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
Address
Maruito Nishi-Umeda Building 3F, 3-3-45 Umeda Kita-ku, Osaka-shi, Osaka 530-0001 Japan
Tel
06-4797-5660
n-irb@ml.taifukukai.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
| 2024 | 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
80
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 24 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 26 | Day |
Date analysis concluded
| 2026 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063782
