Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing the fish oil Administration: Take four capsules per day at any time during the day. *If you forget to take the test food, take it as soon as you r
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who feel reducing vitality 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have relatively lower vitality score in SF-36 at screening
Exclusion criteria
Exclusion criteria: 1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects 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 Functional Claims", or other functional food/beverage as part of their daily intake 5. Subjects regularly taking medications (including herbal medicines) and supplements 6. Subjects allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, lactating, or intending to become pregnant 8. 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 participate another trial during this trial 9. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of vitality of Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36) at 12 weeks after the start of test-food consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of vitality of SF-36 at four and eight weeks after the start of test-food consumption 2. The amount of changes of vitality of SF-36 between screening and four, eight and 12 weeks after the start of test-food consumption 3-1. The measured values of the following items at four, eight and 12 weeks after consumption 3-2. The amount of changes of the following items between screening and four, eight and 12 weeks after the start of test-food consumption [Items] physical component summary (PCS), mental component summary (MCS), role/social component summary (RCS), physical functioning, role physical, bodily pain, general health, social functioning, role emotional, and mental health of SF-36, visual analogue scale (VAS) of fatigue, scoring of immunological vigor, immunological grade, T lymphocyte age (upper limit), scoring of T cells, scoring of CD8+CD28+T cell ratios, scoring of CD4+T cells / CD8+T cells ratio, scoring of naive T cells, scoring of naive T cell/memory T cell ratios, scoring of B cells, scoring of NK cells, number of T cells, CD4+T cells / CD8+T cells ratio, number of naive T cells, naive T cells / memory T cells ratio, number of B cells, number of NK cells, number of CD8+CD28+T cells, moisture of the skin, each score of Japanese rhino-conjunctivitis quality of life questionnaire (JRQLQ) (total score, nasal and eye symptoms score, nasal symptoms score, eye symptoms score, total score of QOL, daily life score, outdoor life score, social life score, sleep score, fatigue score, and emotion score), and salivary immunoglobulin A (sIgA) 4. The measured values of sneezing, runny nose, blocked nose and impacts on daily life at four, eight and 12 weeks after the start of test-food consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed