Healthy Japanese subjects
Conditions
Interventions
Duration: 4 weeks Test Food: Manda Koso Dosage: Take 5 packs per day after breakfast. Take the packs with water as necessary. * If you forget to take the test food, take it as soon as you remember
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese adults who are experiencing daily fatigue 2. Subjects who are judged as eligible to participate in the study by the physician 3. Subjects who have low scoring of immunological vigor at screening (before consumption)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or 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 currently taking medications (including herbal medicines) and dietary supplements 6. Subjects who are allergic to medicines and/or the test food related products especially orange, walnut, sesame seed, soybean, banana, and apple 7. Subjects who are pregnant, breast-feeding, or planning 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 ineligibility to participate in the study based on the evaluation of the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Scoring of immunological vigor 2. T lymphocyte age 3. T cells 4. CD4+/CD8+ T cells ratio 5. Naive T cells 6. Naive/memory T cells ratio 7. B cells 8. NK cells 9. CD8+CD28+ T cells *1-9Assess at 0 and 4 weeks after consuming | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective symptoms (The Likert scale method) *Assess at 0 and 4 weeks after consuming | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed