UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045370 |
|---|---|
| Receipt number | R000051786 |
| Scientific Title | Clinical trials on sleep, stress and mucosal immunity by test food |
| Date of disclosure of the study information | 2021/09/03 |
| Last modified on | 2023/04/17 14:25:52 |
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Basic information
Public title
Clinical trials on sleep, stress and mucosal immunity by test food
Acronym
Clinical trials on sleep, stress and mucosal immunity by test food
Scientific Title
Clinical trials on sleep, stress and mucosal immunity by test food
Scientific Title:Acronym
Clinical trials on sleep, stress and mucosal immunity by test food
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify test food sleep-improving, stress-improving and mucosal immunity effects in human clinical trials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pittsburgh Sleep Quality Index
Key secondary outcomes
(Secondary outcomes)
Saliva s-IgA, VAS, stress record (life questionnaire)
(Safety evaluation)
Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
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
6-weeks intake of the test food
Interventions/Control_2
6-weeks intake of the placebo food
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
| 65 | 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 who is aware of poor sleep quality.
3.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Key exclusion criteria
1.Subject who is taking medication or under medical treatment due to serious illness.
2.Subject who is under exercise therapy or dietetic therapy.
3.Subject who may develop allergies due to the test foods.
4.Subject with current or history of drug and alcohol dependence.
5.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.
6.Subject with irregular life rhythms due to night shifts or shift work.
7.Subject with extremely irregular lifestyle habits such as eating and sleeping.
8.Subject who has an extremely unbalanced diet.
9.Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have.
10.Subject who uses health foods, supplements, and medicines that affect brain function (improvement of sleep) and intestinal function.
11.Subject who uses health foods and supplements that affect immune function.
12.Subject who has participated in other clinical trials (research) within 3 months from the date of consent acquisition, or those who plan to participate in other clinical trials (research) during the trial period.
13.Subject who has collected more than 200 mL of blood or donated more than 400 mL of blood within 1 month or 3 months from the date of consent acquisition.
14.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
15.Subject who has difficulty observing records on various survey forms.
16.Subject who is judged as an inappropriate candidate according to the screening data.
17.Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size
80
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 10F 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 10F 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
Fuji Nihon Seito Corporation
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
| 2021 | Year | 09 | Month | 03 | 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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 14 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 18 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 03 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051786
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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