N/A (healthy adults)
Conditions
Interventions
Oral ingestion of the test product (8 weeks)
Sponsors
Anti-Aging Bank Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 55-69 years [2]Healthy individuals not receiving any medical disease treatment [3]Individuals with knee and/or low back pain in daily life [4]Individuals voluntarily join the study with written informed consent [5]Individuals who can visit study site and receive examinations on designated days [6]Individuals judged appropriate to join this study by principal investigators
Exclusion criteria
Exclusion criteria: [1]Individuals receiving medical drugs for treatment of chronic diseases [2]Individuals receiving outpatient care (except for bonesetters, chiropractors, massagers) for knee and/or low back pain [3]Individuals with history of palliative therapy (hyaluronic acid, steroid injection, etc.) or surgical therapy (arthroscopic osteotomy, artificial joint, bolt fixation surgery, etc.)on knees and/or waist [4]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [5]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc. [6]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [7]Individuals with history of gastrointestinal disorders except for appendicitis [8]Individuals with inflammatory disorders such as chronic sinusitis, periodontal disease, bronchitis, etc. [9]Individuals with >=30.0kg/m2 BMI [10]Individuals donated blood >200ml in past 1 month or >400ml in past 3 months [11]Individuals with serious anemia [12]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs [13]Individuals continually consumed health foods that may interfere the study results (especially glucosamine, chondroitin, etc.) in the past 3 months except for general nutritional supplements [14]Individuals with alcohol intake exceeding 40mg/day,200mg/week as ethanol volume [15]Smokers or ex-smokers within one year after quitting [16]Individuals who may significantly change exercise habit or lifestyle during the study period [17]Individuals participating or planning to join the other clinical investigations during the study period [18]Pregnant or lactating women (expected, desired inclusive) [19]Individual with potential conflict of interests etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Improvement of knee pain (motion range evaluation of knee joints, JCOM, WOMAC)(2W, 4W, 6W, 8W) [2]Improvement of low back pain (JLEQ)(2W, 4W, 6W,8W) | — |
Secondary
| Measure | Time frame |
|---|---|
| [1]Improvement of QOL(Anti-Aging QOL Common Questionnaire) [2]Improvement of inflammation(hs-CRP) [3]Anti-glycation(Pentosidine) [4]Safety(Blood biochemistry etc.) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed