Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Squalene capsule
Duration: 12 weeks Test product: Placebo capsule
Sponsors
ORIHIRO Plantdew Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who experience temporary fatigue in daily life 6. Individuals who are judged by the physician to have no issues with study participation based on the results of the Beck Depression Inventory-Second Edition (BDI-II) at screening 7. Individuals with a large positive fatigue (VAS) value at screening, calculated as after workload minus before workload
Exclusion criteria
Exclusion criteria: Individuals who 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 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. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking or using medicines (including herbal medicines) or supplements 6. are allergic to medicines or foods related to the test product (particularly fish or gelatin) 7. are pregnant, lactating, or planning to become pregnant during this study 8. 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 9. have mental health issues such as depression disorder or attention deficit/hyperactivity disorder 10. are undergoing medical treatment or have a medical history of chronic fatigue syndrome 11. have irregular working patterns, including those involving night shifts 12. work in physical labor such as transportation of heavy objects 13. have irregular lifestyles (whose habits vary every day such as dietary habits, exercise habits, and sleeping habits) 14. consume alcohol in excess daily 15. consume foods containing ingredients that may affect fatigue or stress (e.g., S-allylcysteine, gamma-aminobutyric acid, lactic acid bacteria, reduced Coenzyme Q10, Euglena gracilis-derived paramylon, docosahexaenoic acid, eicosapentaenoic acid, astaxanthin, citric acid, L-Theanine, black soybean polyphenols, 5-aminolevulinic acid phosphate, anserine) 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 measured by Visual Analogue Scale (VAS) at 12 weeks after intervention (12w) [before and after workload: change from before workload to after workload] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change and percentage change in fatigue (VAS) from screening at 12w [before and after workload] 2. The measured value of fatigue (VAS) at 12w, and the change and percentage change from screening [before workload and after workload] 3. The measured values of Total Mood Disturbance score (TMD), Anger-Hostility (AH), Confusion-Bewilderment (CB), Depression-Dejection (DD), Fatigue-Inertia (FI), Tension-Anxiety (TA), Vigor-Activity (VA), and Friendliness (F) in the Profile of Mood States 2nd Edition (POMS2) at 12w [before workload] | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed