Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Pig placenta extract powder (contained in size 3 hard capsule) Administration: Take five capsules with water without chewing after breakfast *If you forget to take t
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 20 or more and less than 65 4. Healthy individuals 5. Individuals whose TMD score in the POMS2 is relatively high among those who have agreed to participate
Exclusion criteria
Exclusion criteria: Individuals 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 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 medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products (particularly pork or horses) 7. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder, or other issues 8. have irregular sleeping time or habit due to work such as a late-night shift 9. have irregular lifestyles (such as diet, exercise, and sleep) 10. are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome 11. work in physical labor such as transportation of heavy objects 12. are undergoing treatment for premenstrual syndrome and/or premenstrual dysphoric disorder 13. are receiving counseling and/or psychotherapy 14. have undergone or are undergoing hormonal therapy 15. are usually taking food containing functional ingredients which may influence fatigue or stress (such as S-allyl cysteine, gamma-aminobutyric acid, lactic acid bacteria, reduced form of coenzyme Q10, paramylon derived from Euglena gracilis, docosahexaenoic acid, eicosapentaenoic acid, astaxanthin, citric acid, L-theanine, polyphenol derived from black soybean, 5-aminolevulinic acid phosphate, or anserine) 16. are pregnant, lactating, or planning to become pregnant during this study 17. have been enrolled in other clinical studies within 28 days before the agreeing to participate or plan to participate another study during this study 18. are judged as ineligible to participate by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of Total Mood Disturbance (TMD) score in the Profile of Mood States 2nd Edition (POMS2) at 12 weeks after consumption (12w) (Intervention 1 vs Intervention 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of TMD score in the POMS2 at 12w (Intervention 2 vs Intervention 3) 2. The measured values of Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), Friendliness (F) in the POMS2 at 12w 3. The measured value of fatigue measured by visual analogue scale at 12w 4. The measured values of Physical Component Summary (PCS), Mental Component Summary (MCS), Role-social Component Summary (RCS), Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), Mental Health (MH) in the MOS Short-Form 36-Item Health Survey at 12w 5. The measured values of "sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," and "sleep length" in the OSA sleep inventory MA version (OSA-MA) at 12w 6. The measured value of each item in the OSA-MA at 12w 7. The measured values of high-sensitivity C-reactive protein, plasma cortisol, dehydroepiandrosterone sulfate at 12w 8. The measured value of each item in the POMS2 at 12w 9. The measured values of each symptom in the questionnaire of Kupperman Konenki Shogai Index (KKSI) at 12w (Women only) 10. The measured values of KKSI and each symptom complex (vasomotor symptoms, paresthesia, insomnia, nervousness, melancholia, vertigo, weakness/fatigue, arthralgia/myalgia, headache, palpitation, and formication) in the questionnaire of KKSI at 12w (Women only) 11. The measured values of estradiol, follicle-stimulating hormone, luteinizing hormone, and progesterone at 12w (Women only) 12. The measured value of free testosterone at 12w (Men only) 13. The measured values of low frequency (LF), high frequency (HF), LF/HF ratio, average heart rate, maximum heart rate, minimum heart rate, total power (TP), coefficient of component variance TP (ccvTP), deviation value of | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed