Healthy Japanese subjects
Conditions
Interventions
Duration: Test food: Food containing fermented Panax ginseng, fermented Korean red ginseng extract, and royal jelly Administration: Take two packets with water without chewing at any time during 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. Subjects aged 40 or more 4. Healthy subjects 5. Subjects who easily catch colds and are concerned about sleep quality 6. Subjects whose scoring of immunological vigor are relatively low at screening (before consumption; Scr)
Exclusion criteria
Exclusion criteria: Subjects (who/whose) 1.undergoing medical treatment or having a medical history of malignant tumor, heart failure, and myocardial infarction 2.have a pacemaker or an ICD 3.undergoing treatment for chronic diseases such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, or hypertension 4.take "Foods for Specified Health Uses," or "Foods with Functional Claims" on daily 5.usually taking medicines (including herbal medicines) or supplements 6.are allergic to medicines or the test food related products 7.are pregnant or lactation / become pregnant 8.have COVID-19 9.have been enrolled in other clinical trials within the last 3 months before the agreement to participate in this trial or plan to participate in another trial during this trial 10.judged as ineligible to participate in the study by the physician 11.working hours are irregular 12.have irregular ifestyles (such as diet, and exercise) 13.sleep habits are irregular 14.usually sleeping less than 6 hours / will sleep less than 6 hours during the test period on daily 15.live with their infants less than one year old 16.sleep with their children (1 to 6 years old) 17. live with requiring long-term care persons 18.sleep with more than one person 19. have nocturia three times or more 20.drink to excess (average of more than about 20 g/day as absolute alcohol intake) 21.take food/beverage containing functional ingredients that may influence immune function, sleep quality, or subjective fatigue/stress 22.have autoimmune disease 23.taking immunosuppressants 24.have perennial allergic rhinitis 25.undergoing treatment for sleep disorder such as insomnia or sleep apnea syndrome 26.smoke 27.have medical history of dermatitis, hypotension, atopy, bronchial asthma, cardiopathy, organ transplantation, psychiatric disorder, HIV/AIDS, short bowel syndrome, arteriosclerosis, histoplasmosis, hypercalcemia, lymphoma, sarcoidosis, or tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Scoring of immunological vigor | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. T lymphocyte age, the rate of CD3+T cells, the number of CD3+T cells, the score of CD3+T cells, the rate of CD4+T cells, the number of CD4+T cells, the rate of CD8+T cells, the number of CD8+T cells, the rate of naive T cells (CD4+), the number of naive T cells (CD4+), the score of naive T cells (CD4+), the rate of memory T cells (CD4+), the number of memory T cells (CD4+), the score of memory T cells (CD4+), CD8+CD28+T cells, the rate of B (CD20+) cells, the number of B cells (CD20+), the score of B cells (CD20+), the rate of NK cells (CD56+CD16-), the rate of NK cells (CD56+CD16+), the rate of NK cells (CD56-CD16+), the number of NK cells, the score of NK cells, the ratio of CD4+/CD8+T cells, the score of ratio of CD4+/CD8+T cells, the ratio of naive T cells to memory T cells, the score of ratio of naive T cells to memory T cells, and immunological grade 2. "Sleepiness on rising", "Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA sleep inventory MA version 3. The total score, "Sleep quality"(C1), "Sleep latency"(C2), "Sleep duration"(C3), "Habitual sleep efficiency"(C4), "Sleep disturbance"(C5), "Use of sleeping medication"(C6), "Daytime dysfunction"(C7), and each items in Pittsburgh Sleep Quality Index 4. Sleep score, sleep onset, sleep offset, midpoint of sleep, time in bed after sleep offset, sleep onset latency, StageR latency, NotScored total time, N1 total time, N2 total time, N3 total time, REM (rapid eye moving) total time, total sleep time (TST), wake time after sleep onset (WASO), sleep efficiency[%total recording time (TRT)], percentage of N1[%TST], percentage of N2[%TST], percentage of N3[%TST], and percentage of REM[%TST] in sleep test 5. LF (low frequency), HF (how frequency), LF/HF ratio, average heart rate, maximum heart rate, minimum heart rate, TP | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed