UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048798 |
|---|---|
| Receipt number | R000055586 |
| Scientific Title | Confirmatory study of the improving effect of sleep quality by test-food intake |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/01/05 16:08:21 |
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Basic information
Public title
Confirmatory study of the improving effect of sleep quality by test-food intake
Acronym
Confirmatory study of the improving effect of sleep quality by test-food intake
Scientific Title
Confirmatory study of the improving effect of sleep quality by test-food intake
Scientific Title:Acronym
Confirmatory study of the improving effect of sleep quality by test-food intake
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effect of the test food on sleep quality by having healthy adults between the ages of 20 and 65 consume it for 8 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sleep quality
Key secondary outcomes
(Secondary outcomes)
Indexes on sleeping,Tests for mood status
(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
8-weeks intake of the test food
Interventions/Control_2
8-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 males and femaless who are between 20 and 65 years old at the time of obtaining written consent.
2.Subject who is aware of poor sleep quality.
3.Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria
1.Subject who is taking medication or under medical treatment because of some serious illness.
2.Subject who is under exercise therapy or dietetic therapy under the supervision of a physician.
3.Subject who has an allergy for test food.
4.Subject who has or had a history of either medicine or alcohol dependence syndrome.
5.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders(Insomnia, sleep apnea syndrome, etc.), 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 who has extremely irregular lifestyle habits such as eating and sleeping.
8.Subject who has an extremely unbalanced diet.
9.Subject with serious current or history of brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases.
10.Subject who uses health foods, supplements, medicines that contain ingredients that affect sleep quality.
11.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.
12.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.
13.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
14.Subject who has difficulty observing records on various survey forms.
15.Subject judged to be inappropriate as subjects based on clinical laboratory test values and measured values at the time of SCR.
16.Others who are judged by the investigator to be inappropriate as subjects.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Matsuoka |
| Middle name | |
| Last name | Matsuoka |
Organization
M&I Science CORP.
Division name
Clinical Development Department
Zip code
531-0071
Address
NAKATSUGRAND Bld.10F, 1-17-26, Nakatsu, Kita-ku, Osaka-Shi, Osaka, Japan
TEL
06-7878-6780
m.matsuoka@mis21.co.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
M&I Science CORP.
Division name
Clinical Development Department
Zip code
531-0071
Address
NAKATSUGRAND Bld.10F, 1-17-26, Nakatsu, Kita-ku, Osaka-Shi, Osaka, Japan
TEL
06-7878-6780
Homepage URL
m.matsuoka@mis21.co.jp
Sponsor or person
Institute
M&I Science CORP.
Institute
Department
Personal name
Funding Source
Organization
KOKUYO Co.,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
| 2022 | Year | 09 | Month | 01 | 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
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 | 07 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055586
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| Registered date | File name |
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