UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041864 |
|---|---|
| Receipt number | R000047793 |
| Scientific Title | Effects of consumption of the test food on sleep quality: A randomized, double-blind, placebo-controlled, parallel-group comparison trial |
| Date of disclosure of the study information | 2022/02/19 |
| Last modified on | 2021/06/29 15:06:16 |
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Basic information
Public title
Effects of consumption of the test food on sleep quality
Acronym
Effects of consumption of the test food on sleep quality
Scientific Title
Effects of consumption of the test food on sleep quality: A randomized, double-blind, placebo-controlled, parallel-group comparison trial
Scientific Title:Acronym
Effects of consumption of the test food on sleep quality
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on sleep quality of healthy Japanese subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of sleep quality by a sleep test
Key secondary outcomes
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
The test food
Duration: 12 weeks
Interventions/Control_2
The placebo food
Duration: 12 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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adult subjects who age 45 or more
2. Subjects who are anxious about their sleep quality
3. Subjects who have been fully informed of the purpose and content of this trial, have the capacity to consent, understand it well, voluntarily participate in the study, and agree to participate in this trial
Key exclusion criteria
Subjects who
1. undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction, and have a pacemaker or an implantable cardioverter defibrillator
2. undergoing treatment for cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
3. use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage such as gamma-aminobutyric acid, crocetin, L-theanine, lactic acid bacteria that may affect sleep quality in daily
4. currently taking medicines (include herbal medicines) and supplements
5. allergic to medications and/or the test-food-related products. Particularly, gelatin or fish allergy
6. have factors that affect their sleep due to their home environment
7. Subjects who have irregular sleep habits due to irregular lifestyles (irregular meal timing, insufficient sleep, or night shifts, etc.)
8. have nocturia 3 times or more
9. drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}
10. pregnant, breast-feeding, and planning to become pregnant
11. have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
12. under treatment of sleeplessness or sleep disorder
13. judged as ineligible to participate in the study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
planning-department@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Nippon Suisan Kaisha, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | 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
66
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
| 2020 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 23 | Day |
Last modified on
| 2021 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047793
