UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051261 |
|---|---|
| Receipt number | R000058456 |
| Scientific Title | Effects of consumption of the test food on sleep quality in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/12/16 |
| Last modified on | 2025/10/10 12:22:57 |
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Basic information
Public title
Effects of consumption of the test food on sleep quality in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of consumption of the test food on sleep quality in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of consumption of the test food on sleep quality in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on sleep quality in healthy Japanese subjects
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 in healthy Japanese subjects
Basic objectives2
Safety,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" in the OSA sleep inventory MA version (OSA-MA) at 12 weeks after consumption (12w)
Key secondary outcomes
1.The measured values of "sleepiness on rising" in the OSA-MA at 4 and 8 weeks after consumption (4w, 8w)
2.The amount and rate of change of "sleepiness on rising" in the OSA-MA between screening (before consumption; Scr) and 4w, 8w, or 12w
The below items (No. 3~4) at 4w, 8w, and 12w, and the amount and rate of changes of them from Scr will be measured
3."Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA-MA
4.Each item in an original questionnaire
The below items (No. 5~9) at 12w, and the amount and rate of changes of them from Scr will be measured
5.Total score, C1, C2, C3, C4, C5, C6, C7, and each item in the Pittsburgh Sleep Quality Index (PSQI-J)
6.Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), Friendliness (F), and each item in the Profile of Mood States 2nd Edition (POMS2)
7.Sleep score, sleep onset, sleep offset, midpoint of sleep, time in bed after sleep offset, sleep onset latency, StageR latency, NotScored total time, N1 total time, N2 total time, N3 total time, rapid eye moving (REM) total time, total sleep time (TST), wake time after sleep onset (WASO), sleep efficiency[%total recording time (TRT)], percentage of N1[%TST], percentage of N2[%TST], percentage of N3[%TST], and percentage of REM[%TST] in the sleep test
8.Blood flow and palmar surface temperature (with cold water load)*
*Assessment items: The measured values at each time point, area under the curve (AUC) from immediately after load, and the amount of changes from before and immediately after load to each time point respectively
Time points: Before load, immediately after load, 5, 10, 20, and 30 minutes after load
9.Oxidative stress markers {8-hydroxy-2'-deoxyguanosine (8-OHdG), thiobarbituric acid reactive substances (TBARS)}, nitric oxide (NO) metabolites, and pentosidine in the blood test
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Capsule containing black soybean polyphenols
Administration: Take one capsule with water after dinner once daily
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: 12 weeks
Test food: Capsule not containing black soybean polyphenols
Administration: Take one capsule with water after dinner once daily
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Subjects aged 30 or more and 65 or less
4. Healthy subjects
5. Subjects who are dissatisfied with their subjective fatigue upon waking and sleep quality (such as short sleep time, difficulty falling asleep, difficulty sleeping soundly, dreaming, and persistent fatigue) in daily life
6. Subjects who are judged as eligible to participate in the study by the physician according to the results of the Beck depression inventory (BDI-II) at Scr
7. Subjects who have low "sleepiness on rising" score in the OSA-MA among those meeting 1. ~ 6. and not meeting the exclusion criteria at Scr
Key exclusion criteria
Subjects who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. are currently taking medications (including herbal medicines) and supplements
6. are allergic to medicines and/or the test food related products (particularly, soybeans, pollen, or milk)
7. are pregnant, lactating, or planning to become pregnant during this trial
8. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
9. are judged as ineligible to participate in this study by the physician
10. live with their infants less than one year old
11. sleep with their children (1 to 6 years old)
12. live with and need to care for those in requiring long-term care
13. sleep with more than one person
14. have irregular sleeping time or habit is due to work such as a late-night shift
15. have nocturia two times or more
16. have irregular lifestyles (such as inconstant eating time, insufficient sleeping time)
17. 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)}
18. are currently undergoing treatment of insomnia or sleep disorder
19. take food/beverage containing functional ingredients which may influence sleep quality (such as gamma-aminobutyric acid, crocetin, L-theanine, and lactic acid bacteria)
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Fujicco 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 | 12 | Month | 16 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/fsn3.70156
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/fsn3.70156
Number of participants that the trial has enrolled
64
Results
Described in reference 1
Reference 1: Akagi, R., Maruo, T., Takara, T., & Maruyama, K. (2025). Effects of Consumption of Black Soybean Seed Coat Extract on Sleep Quality in Healthy Japanese: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study. Food science & nutrition, 13(6), e70156. https://doi.org/10.1002/fsn3.70156
Results date posted
| 2025 | Year | 10 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 06 | Month | 11 | Day |
Baseline Characteristics
Described in reference 1
Participant flow
Described in reference 1
Adverse events
Described in reference 1
Outcome measures
Described in reference 1
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 17 | 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 | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058456
