N/A(healthy adults)
Conditions
Interventions
Oral ingestion of a test food (one time in a day
12 weeks).
Oral ingestion of a placebo food (one time in a day
12 weeks).
Sponsors
TES Holding Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Healthy Japanese males and females aged 40-75 years. [2]Individuals who are healthy and have no chronic physical disease. [3]Individuals who are aware of knee pain. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can have an examination on a designated check day. [6]Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products. [2]Individuals receiving outpatient care (except for bonesetters, chiropractors, massagers) for knee and/or low back pain. [3]Individuals who are a patient or have a history of rheumatic disease. [4]Individuals whose grade of Kellgren-Lawrence grading system is over Grade II. [5]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. [6]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders. [7]Individuals who are a patient or have a history of receiving medical drug treatment for the past 1 month (except for temporary relief medication for headache, menstrual pain, common cold). [8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [9]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [11]Individuals with serious anemia. [12]Individuals who are sensitive to test product or other foods, and medical products. [13]Individuals having a habit to intake a food containing the component of the test food. [14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [15]Individuals who may significantly change exercise habit or lifestyle during the study period. [16]Individuals who are or are possibly, or are lactating. [17]Individuals who participated in other clinical studies in the past 3 months. [18]Individual with potential conflict of interests. [19]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Japanese Knee Osteoarthritis Measure (JKOM; Screening, Week 0, Week 4, Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1]The Japan Orthopaedic Association Score (JOA Score; Screening, Week 0, Week 4, Week 12). [2]The 25-question geriatric locomotive function scale (Screening, Week 0, Week 4, Week 12). [3]Stand-up test (Screening, Week 0, Week 4, Week 12). [4]2-step test (Screening, Week 0, Week 4, Week 12). [5]Timed up & go test (Screening, Week 12). *Safety [1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 12). [2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 12). [3]Hematologic test (Screening, Week 0, Week 12). [4]Blood biochemical test (Screening, Week 0, Week 12). [5]Urine analysis (Screening, Week 0, Week 12). [6]Doctor's questions (Screening, Week 0, Week 4, Week 12). [7]Subject's diary (From the first day of ingestion of a test material to the last day of the test). *Other index [1]Evaluation of knee with Kellgren-Lawrence grading system (Screening). | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holding Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed