UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052562 |
|---|---|
| Receipt number | R000059972 |
| Scientific Title | A study to evaluate how the intake of the test beverage and the watching of a video while taking it impacts psychology and cognitive functioning. |
| Date of disclosure of the study information | 2023/10/20 |
| Last modified on | 2023/12/20 11:02:09 |
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Basic information
Public title
A study to evaluate how the intake of the test beverage and the watching of a video while taking it impacts psychology and cognitive functioning.
Acronym
A study to evaluate how the intake of the test beverage and the watching of a video while taking it impacts psychology and cognitive functioning.
Scientific Title
A study to evaluate how the intake of the test beverage and the watching of a video while taking it impacts psychology and cognitive functioning.
Scientific Title:Acronym
A study to evaluate how the intake of the test beverage and the watching of a video while taking it impacts psychology and cognitive functioning.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the psychological and cognitive functionin effects on ingesting the test beverage and the watching of a video while taking it 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
Global local task
Key secondary outcomes
(Secondary outcomes)
Psychological questionnaire, Twenty statements test, gaze measurement
(Safety evaluation)
Vital signs, physical measurements (body weight and BMI), 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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake placebo beverage on the day
Interventions/Control_2
Intake test beverage on the day
Interventions/Control_3
Watch a video while taking the placebo beverage on the day
Interventions/Control_4
Watch a video while taking the test beverage on the day
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 who are aged 20 years or over and less than 35 at the time of obtaining informed consent.
2.Subjects who are able to properly wear VR goggles or glass-type eye trackers (e.g., those with the naked eye or contact lens wearers).
3.Subjects who do not reject the flavor of the test beverage.
4.BMI less than 30 kg/m2.
5.Non-smokers (who did not smoke in the last 1 year).
6.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.
Key exclusion criteria
1.Subjects receiving medication or outpatient treatment for a serious disease.
2.Subjects receiving exercise or diet therapy under the supervision of a physician.
3.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder or have previous history of a psychiatric disorder.
4.Subjects with a history or current illnesses of serious diseases such as heart, liver, kidneys, digestive organs, brain, malignant tumors, immune diseases, diabetes, etc.
5.Subjects who feel they are susceptible to motion sickness or visually induced motion sickness.
6.Heavy drinker.
7.Subjects who have difficulty quitting drinking from the day before the test date.
8.Subjects who have extremely irregular eating habits, those who have an extremely irregular rhythm of life, such a those who work in shifts or late at night.
9.Subjects who are participating in other clinical trials at the time of obtaining consent, and who plan to participate in other clinical trials within 4 weeks from the end of the study to the start of the main study of the study, or after consenting to participate in the study.
10.Subjects who have moved residences, changed jobs, separated from close relatives, or had equivalent events within the last 3 months and thus are likely to be under a great deal of stress, or who may have such an event during the study period.
11.Subjects with severe PMS (premenstrual syndrome) symptoms.
12.Females who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period.
13.Subjects with perennial allergic rhinitis.
14.Subjects who may develop allergies related to the study.
15.Subjects with current or previous history of drug dependence or alcohol dependence.
16.Subjects who unable to comply during the study period.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@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
Miyake Clinic Institutional Review Board
Address
4-2-17 Komagome, Toshima-ku, Tokyo 170-0003 Japan
Tel
03-6903-7211
jim@medipharma.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
| 2023 | Year | 10 | Month | 20 | 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
120
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
| 2023 | Year | 10 | Month | 12 | 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 | 12 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 13 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059972
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