UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055992 |
|---|---|
| Receipt number | R000063987 |
| Scientific Title | Effects of consumption of the test food on sleep quality: a randomized, placebo-controlled, double-blind, crossover comparison study |
| Date of disclosure of the study information | 2024/10/30 |
| Last modified on | 2025/01/31 16:49:45 |
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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, placebo-controlled, double-blind, crossover comparison study
Scientific Title:Acronym
Effects of consumption of the test food on sleep quality
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized, placebo-controlled, double-blind, crossover comparison study will be conducted to verify the effect of continuous consumption for four weeks of the test food on sleep quality in healthy Japanese with concerns about sleep quality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of sleepiness on rising measured by visual analogue scale (VAS) at four weeks after intervention (4w)
Key secondary outcomes
1. The amount of change of sleepiness on rising measured by VAS between before intervention and 4w
2. The measured value and the amount of change from before intervention of subjective fatigue measured by VAS at 4w
3. The measured values and the amount of changes from before intervention of "sleepiness on rising", "Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA sleep inventory MA version (OSA-MA) at 4w
4. Sleep time, sleep stage (each time of rapid eye movements (REM) sleep, light sleep and deep sleep) and sleep score (sleep quality)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Four weeks
The test food
Interventions/Control_2
Duration: Four weeks
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals who are dissatisfied with their sleep
Key exclusion criteria
Individuals who/whose
1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2.have a pacemaker or an implantable cardioverter defibrillator
3.are currently undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, immune disease, or other chronic diseases
4.are undergoing medical treatment or have a medical history for psychiatric disorder (e.g., depression), sleep apnea syndrome, hypersomnia, narcolepsy, insomnia, or heart valve disease
5.are aware of snore, excessive daytime sleepiness, awakening with a feeling of choking during sleep, panting, insomnia, or remarks from others about interrupted breathing during sleep
6.are smokers
7.have quit smoking within 3 months before agreeing to participate
8.consume foods that improve or inhibit sleepiness before sleep
9.use products that improve or inhibit sleepiness before sleep
10.sleeping habits are irregular due to night shifts and other lifestyle reasons
11.are night workers, shift workers or hard workers
12.sleep in the same room with more than one person, live with preschool children or care recipients, may be disturbed from sleep by others
13.may undergo surgery or tooth extraction during the intervention period
14.are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
15.are taking or using medications (including herbal medicines) and supplements
16.have allergies (medicines and the test food related products), especially milk
17.are pregnant, lactating, or planning to become pregnant during this study
18.have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
19.are judged as ineligible to participate in this study by the physician
Target sample size
160
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
NISSIN YORK CO., 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 Bldg., 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
| 2024 | Year | 10 | Month | 30 | 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
176
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 | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 28 | 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 | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063987
