UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048921 |
|---|---|
| Receipt number | R000055735 |
| Scientific Title | A study for evaluating effects of a single intake of the test beverage on EEG and autonomic nervous system. |
| Date of disclosure of the study information | 2023/09/12 |
| Last modified on | 2023/07/20 12:17:46 |
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Basic information
Public title
A study for evaluating effects of a single intake of the test beverage on EEG and autonomic nervous system.
Acronym
A study for evaluating effects of a single intake of the test beverage on EEG and autonomic nervous system.
Scientific Title
A study for evaluating effects of a single intake of the test beverage on EEG and autonomic nervous system.
Scientific Title:Acronym
A study for evaluating effects of a single intake of the test beverage on EEG and autonomic nervous system.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of the test beverage on the EEG and autonomic nervous in Japanese men and women between the ages of over 20 and under 35.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG sensor measurement data
Key secondary outcomes
(Secondary outcomes)
Psychological evaluation questionnaire,Heart rate sensor measurement data.
(Safety evaluation)
Vital signs, physical measurements (weight, BMI),adverse events.
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
In take placebo beverage A on the day.
Washout.
In take placebo beverage B on the day.
Washout
In take test beverage on the day.
Interventions/Control_2
In take test beverage on the day.
Washout.
In take placebo beverage A on the day.
Washout.
In take placebo beverage B on the day.
Interventions/Control_3
In take placebo beverage B on the day.
Washout.
In take test beverage on the day.
Washout.
In take placebo beverage A 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.Japanese male and female who are between 20 and 35 years old at the time of obtaining written consent.
2.Subject with BMI <25kg/m2.
3.Non-smokers (no smoking in the last year)
4.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing.
Key exclusion criteria
1.Subject who is taking medication or under medical treatment due to illness.
2.Subject who is taking foods for specified health use, foods with functional claims, health foods (including supplements) that affect the autonomic nervous system, metabolism, and sleep, and cannot stop taking them during the test period.
3.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past.
4.Subject with a history of serious diseases such as heart, liver, kidneys, digestive organs, brain, malignant tumors, immune diseases, diabetes, etc.
5.Subject with defects in EEG and heart rate measurements (abundance chest hair, use of a pacemaker, skin rash, etc.)
6.Heavy drinker.
7.Subject who has difficulty quitting drinking from the day before the test date.
8.Subject who has extremely irregular eating habits, those who work shifts, those who work late at night, etc.
9.Subject who is participating in other clinical trials at the time of obtaining consent, and who plans 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.Subject who is likely to be under great stress due to moving, changing jobs, separation from close relatives, etc. within the last 3 months.
11.Subject who exercises violently on a daily basis.
12.Subject with severe PMS (premenstrual syndrome) symptoms.
13.Subject who is planning to get pregnant during the test period after the day of informed consent or is currently pregnant and lactating.
14.Subject with hay fever or allergic rhinitis (seasonal or perennial)
15.Subject who is allergic to medicines and food.
16.Subject who has or had a history of either medicine or alcohol.
17.Subject who can't keep the daily records.
18.Subject who the investigator has determined that participation in this study is inappropriate.
Target sample size
24
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
NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
Address
Maruito Nishi-Umeda Building 3F, 3-3-45 Umeda Kita-ku, Osaka-shi, Osaka-fu, 530-0001, Japan
Tel
06-4797-5660
kanri@ml.amc-clinic.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 | 09 | Month | 12 | 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
24
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
| 2022 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 12 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055735
