Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Raw royal jelly capsule Administration: Take 4 capsules with water once a day at any time of the day * Daily dose must be taken within the day.
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult 2. Subjects who feel fatigue in daily and difficult to recover 3. Subjects who are judged as eligible to participate in the study by the physician 4. Within the subjects who met 1st to 3rd inclusion criteria, select subjects with relatively high score in VAS of fatigue.
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are diagnosed with menopausal syndrome 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who have experienced allergic reactions to bee stings 8. Subjects who have the medical history or under the treatment of asthma 9. Subjects who have the medical history or under the treatment of atopy 10. Subjects who are hypotension 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, lactation, or planning to become pregnant 13. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 14. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS) of fatigue * Conform to the methods of Japanese Society of Fatigue Science * Assess the measured value at screening (before consumption) and at 12 weeks after consumption or calculate the amount of change. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Urinary 8-OHdG 2. Simplified Menopausal Index (SMI) 3. OSA sleep inventory MA version 4. Subjective symptoms (The Likert scale method) 5. Blood estradiol level 6. Blood free testosterone level 7. Blood lymphocytes / neutrophils ratio *1-3, 5-7 Assess the measured value at screening (before consumption) and at 12 weeks after consumption or calculate the amount of change. *4 Assess the measured value at screening (before consumption) and at 12 weeks after consumption. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed