UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057986 |
|---|---|
| Receipt number | R000066288 |
| Scientific Title | Effects of consumption of the test food on psychological stress: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/05/27 |
| Last modified on | 2025/09/11 17:02:40 |
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Basic information
Public title
Effects of consumption of the test food on psychological stress
Acronym
Effects of consumption of the test food on psychological stress
Scientific Title
Effects of consumption of the test food on psychological stress: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on psychological stress
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of four weeks of consumption of the test food on psychological stress in healthy Japanese adult men and women who are aware of fatigue, as well as to examine its secondary effect on sleep quality and psychological test results.
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 Fatigue-Inertia (FI) in the Japanese version of the Profile of Mood States 2nd Edition (POMS2) between before and after psychological stress load (after load minus before load) at four weeks after intervention (4w)
Key secondary outcomes
1. The measured values of Total Mood Disturbance (TMD), Anger-Hostility (AH), Confusion-Bewilderment (CB), Depression-Dejection (DD), Tension-Anxiety (TA), Vigor-Activity (VA), and Friendliness (F) in the POMS2 between before and after psychological stress load (after load minus before load) at 4w
2. The measured values of TMD, AH, CB, DD, FI, TA, VA, and F in the POMS2 before and after psychological stress load at 4w
3. The measured values of "Sleepiness on rising (Zc score)," "Initiation and maintenance of sleep (Zc score)," "Frequent dreaming (Zc score)," "Refreshing (Zc score)," "Sleep length (Zc score)," and each item (Zc score) in the OSA sleep inventory MA version (OSA-MA), average work quantity, curve deviation, corrected curve deviation, number of errors in three lines, late increase, primacy effect rate before and after break, fluctuation rate before and after break, and rest effect rate in the Uchida-Kraepelin performance test at 4w
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
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: 4 weeks
Test product: Capsule containing scallop extract
Administration: Take two capsules per day with water before breakfast.
*If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: 4 weeks
Test product: Placebo food
Administration: Take two capsules per day with water before breakfast.
*If you forget to take the test food, take it as soon as you remember. The 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
| 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 aware of fatigue
6. Individuals whose FI in the POMS2 after psychological stress load is higher than that before psychological stress load, and whose FI between before and after psychological stress load is large at screening
7. Individuals who are judged as eligible to participate in this study by the physician according to the results of the Beck Depression Inventory 2nd Edition (BDI-II) at screening
Key exclusion criteria
Individuals (who / whose)
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, depression, attention-deficit/hyperactivity disorder, or other psychiatric disorders
2. have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. working pattern includes a late-night shift or early morning work
5. feel that their sleeping time are irregular
6. have a disability of both hands by injuries, surgeries, or other reasons
7. take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional foods/beverages
8. are taking or using medications (including herbal medicines) or supplements
9. feel that their lifestyles (such as diet, exercise, or sleep) are irregular
10. live with infants (age <1)
11. sleep in the same room with children aged 1~5
12. take foods that they consider to have a relaxing effect at least once a week
13. are allergic to medicines or foods related to the test product, particularly those who are allergic to shellfish or crustaceans such as shrimps and crabs
14. are pregnant, lactating, or planning to become pregnant during this study
15. 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
16. are judged as ineligible to participate in this 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
nao@orthomedico.jp
Sponsor or person
Institute
B&S corporation Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
B&S corporation Co., 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
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
| 2025 | Year | 05 | Month | 27 | 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
68
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
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 09 | 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
| 2025 | Year | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066288
