UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050900 |
|---|---|
| Receipt number | R000058009 |
| Scientific Title | Study on psychological changes at ingestion of the test product. |
| Date of disclosure of the study information | 2024/04/21 |
| Last modified on | 2023/10/11 09:16:24 |
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Basic information
Public title
Study on psychological changes at ingestion of the test product.
Acronym
Study on psychological changes at ingestion of the test product.
Scientific Title
Study on psychological changes at ingestion of the test product.
Scientific Title:Acronym
Study on psychological changes at ingestion of the test product.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The relaxing effect of the test beverage will be examined for Japanese men and women between 20 and 35 years of age.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological evaluation questionnaire
Key secondary outcomes
(Secondary outcomes)
Heart rate sensor measurement data.
(Safety evaluation)
Vital signs, physical measurements (body weight, BMI), adverse events.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Intake test beverage on the day.
Washout.
Intake placebo beverage on the day.
Interventions/Control_2
Intake placebo beverage on the day.
Washout.
Intake test beverage on the day.
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 who are between 20 and 35 years of age at the time of written informed consent.
2.Subject with BMI <30kg/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, has 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 receiving medication or outpatient treatment for a serious disease.(Use on a PRN(as needed) basis will be permitted.)
2.Subject receiving exercise or diet therapy under the supervision of a physician.
3.Subject who has currently taking any products (e.g., foods for specified health use, foods with functional claims, dietary supplements or health foods, drugs, quasi-drugs) that can affect the autonomic nervous system, metabolism, or sleep, and are unable to discontinue taking them during the study period.
4.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past.
5.Subject with a history or current illnesses of serious diseases such as heart, liver, kidneys, digestive organs, brain, malignant tumors, immune diseases, diabetes, etc.
6.Subject who has problems with heart rate measurement (thick chest hair, using a pacemaker, rash on the skin (chest), etc.)
7.Heavy drinker.
8.Subject who has difficulty quitting drinking from the day before the test date.
9.Subject who has extremely irregular eating habits, those who work shifts, those who work late at night, etc.
10.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.
11.Subject who has 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.
12.Subject who exercises violently on a daily basis.
13.Subject with severe PMS (premenstrual syndrome) symptoms.
14.Subject who is planning to get pregnant during the test period after the day of informed consent or is currently pregnant and lactating.
Target sample size
54
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
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga, Setagaya-ku, Tokyo, 158-0097 Japan
Tel
03-5491-4478
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
| 2024 | Year | 04 | Month | 21 | 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
54
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
| 2023 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 26 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 06 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
(Exclusion criteria continued)
15.Subject with seasonal (spring) pollinosis or perennial allergic rhinitis.
16.Subject who is allergic to medicines and food.
17.Subject with current or former drug or alcohol dependence.
18.Subject who has constitutionally incapable of drinking alcohol.
19.Subject who unable to comply during the study period.
20.Subject who the investigator has determined that participation in this study is inappropriate.
Management information
Registered date
| 2023 | Year | 04 | Month | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058009
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
