Healthy Japanese
Conditions
Interventions
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
Sponsors
B&S corporation Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed