UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056226 |
|---|---|
| Receipt number | R000064239 |
| Scientific Title | Study of effects on sleep by the intake of food for healthy subjects |
| Date of disclosure of the study information | 2024/11/21 |
| Last modified on | 2025/02/21 15:51:34 |
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Basic information
Public title
Study of effects on sleep by the intake of food for healthy subjects
Acronym
Study of effects on sleep by the intake of food for healthy subjects
Scientific Title
Study of effects on sleep by the intake of food for healthy subjects
Scientific Title:Acronym
Study of effects on sleep by the intake of food for healthy subjects
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of food on sleep after 4 weeks of ingestion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
OSA-MA
Key secondary outcomes
AIS, PSQI-J, POMS2-AS scores, serum DHEA-S, serum cortisol, the ratio of serum DHEA-S and serum cortisol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 4 consecutive weeks
Interventions/Control_2
Intake of placebo for 4 consecutive weeks
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 59 years of age
(2) Subjects whose average score for the 5 factors of OSA-MA in the pre-test is less than 50
(3) Subjects who fully understand the purpose and content of the study and voluntarily agree to participate in the study
Key exclusion criteria
(1)Subjects who cannot eat one pack of test food every day
(2)Subjects who have irregular sleeping environment, sleeping time and waking time on weekdays
(3)Subjects who are a day shift worker or is involved in manual labor such as heavy object transportation and subjects whose working days and non- working days are irregular
(4)Subjects who have difficulty in carrying out OSA-MA records
(5)Subjects who are in the habit of consuming alcohol on a daily basis
(6)Subjects who have environment that disturbs sleep
(7)Subjects who have the disease requiring regular medication
(8)Subjects who are under treatment or a history of sleep apnea syndrome or are strongly suspected of having sleep apnea syndrome
(9)Subjects who have or are suspected of having nocturia, benign prostatic hyperplasia, or an overactive bladder
(10)Subjects who have history of mental illness, chronic fatigue syndrome, Hypertension, diabetes, or dyslipidemia
(11)Subjects who are under treatment or have a history of serious diseases (e.g., liver disease, kidney disease, heart disease, lung disease, or blood disease)
(12)Subjects who have possibilities for emerging allergy related to a food allergy
(13)Subjects who have pollinosis that needs taking medicine
(14)Subjects who Have a BMI of 30 or more
(15)Subjects who have possibilities for changing lifestyle during the study period
(16)Subjects who plan to become pregnant or breastfeed during the study period
(17)Subjects who have participated in other human clinical trials, or subjects who have participated in other clinical trials within one month prior to obtaining consent to participate in this study
(18)Subjects who are judged to be inappropriate as study subjects based on their answers to the lifestyle questionnaire
(19)Subjects who are judged to be inappropriate as study subjects based on the results of the pre-test
(20)Subjects deemed inappropriate as study subjects by the principal investigator or the investigator for other reason
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Jyoto |
| Middle name | |
| Last name | Yoshimoto |
Organization
Mizkan Holdings Co.,Ltd.
Division name
Central Research Institute
Zip code
475-8585
Address
2-6 Nakamuracho, Handa, Aichi
TEL
080-1576-3917
yoshimoto_jyoutou@mizkan.co.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Bansho |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-3023-8209
Homepage URL
bansho.yoshimi189@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mizkan Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.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
メディカルステーションクリニック (Medical station clinic) (東京都)、医療法人社団 きんせい湯 神楽坂泌尿器科クリニック (Kagurazaka Urology Clinic) （東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | 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
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
| 2024 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 21 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064239
