UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052248 |
|---|---|
| Receipt number | R000059633 |
| Scientific Title | Verification of efficacy of the test foods on sleep quality. |
| Date of disclosure of the study information | 2023/09/19 |
| Last modified on | 2024/10/21 13:41:11 |
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Basic information
Public title
Verification of efficacy of the test foods on sleep quality.
Acronym
Verification of efficacy of the test foods on sleep quality.
Scientific Title
Verification of efficacy of the test foods on sleep quality.
Scientific Title:Acronym
Verification of efficacy of the test foods on sleep quality.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nephrology | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of the test foods on improvement quality of sleep in healthy Japanese adults, who are not satisfied with their quality of sleep.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep EEG (Telemetric electroencephalograph InSomnograph M2)
Key secondary outcomes
OSA-MA (drowsiness upon awakening ,initiation and maintenance of sleep, frequent dreaming, refreshing, sleep length), PSQI, JESS
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
Daily intake of test food for 4 weeks
Interventions/Control_2
Daily intake of placebo (control food) for 4 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy Japanese men and women who are 20 years of age or older at the time of consent.
2.Those who are not satisfied with their sleep quality.
3.Those who can set the room temperature in his/her bedroom at a temperature suitable for sleeping.
4.Those who have regular and stable menstrual cycle (Those who can avoid the period to get the sleep test).
5.Those who have signed a consent prior to the start of the study upon full explanation of the purpose and content of the study.
Key exclusion criteria
1.Those who are students.
2.Those who are on treatment for a serious illness.
3.Those who are at late night work, shift work, or heavy work.
4.Those whose sleep time or sleep habits are irregular on weekdays.
5.Those who visit the hospital because of mental disorders(depression etc.) or sleep disorders, or who have been diagnosed with mental disorders.
6.Those who have been diagnosed as Sleep Apnea Syndrome or have subjective symptoms of apnea.
7.Those who have symptoms of nocturia. Or, those who are on medication for urinary disease.
8.Those who select"I would like to kill myself." or "I would kill myself if I had the chance."at question 9 of BDI2 at the screening test.
9.Those who are habitual smokers.
10.Those who consume excessive alcohol or caffeine(e.g., have been diagnosed with alcoholism or caffeine addiction)
11.Those who do not habitually drink caffein contained beverages such as green tea and coffee.
12.Those who are in the habit of consuming foods that inhibit sleepiness before bedtime or using devices that inhibit sleepiness.
13.Those with metal allergy (skin problems due to electrodes), persons with weak skin.
14.Those who may be prevented from sleep by others.
15.Those with food allergies.
16.Those who regularly use licensed drugs or quasi-drugs that may affect the study.
17.Those who regularly use health foods that may affect the study.
18.Those who are participating in a clinical trial or have participated in another clinical trial within 1 months before the date of consent for this study.
19.Those who are unable to maintain their daily routine during the study.
20.Those whose sleep pattern may change during the study due to travel abroad or business trips.
21.Those who plan to participate in any other clinical trial during the study.
22.Those who have severe symptoms of PMS or menopausal disorders.
23.Those who plan to participate in any other clinical trial during the study.
24.Those who are deemed inappropriate for this study by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kobayashi |
Organization
ITO EN, LTD.
Division name
Central Research Laboratory
Zip code
421-0516
Address
21, Megami, Makinohara City, Shizuoka, Japan
TEL
0548-54-1247
m-kobayasi@itoen.co.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Mizuuchi |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Department Clinical Operations Division
Zip code
103-0027
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo, JAPAN
TEL
03-6386-8809
Homepage URL
m-mizuuchi@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
ITO EN, 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 Review Committee of Watanabe Hospital
Address
1-5-6, Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
food-contact@apoplus.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
医療法人社団 渡辺病院(Watanabe Hospital)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 19 | 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
| 2023 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 19 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059633
