Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test food: Powder containing proteoglycan Administration: Take one pack, once a day with dinner. * If you forget to take the test food, take it before going to bed.
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who age between 20 and 59 when they provide written informed consent 3. Subjects between 22 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI) 4. Subjects who are judged as eligible to participate in the study by the physician 5. Subjects who have relatively high Body fat percentage 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, and 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 Functional Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, and 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 drink alcoholic beverages immoderately 10. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body fat percentage * Assess the measured value at screening (before consumption) and at four weeks after the start of test-food consumption and calculate the amount of change. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body weight 2. Body Mass Index 3. Muscle mass 4. Lean body mass 5. Abdominal circumference 6. Japanese Knee Osteoarthritis Measure (JKOM) 6-1. The score of visual analogue scale; VAS 6-2. The total score 6-3. The score of pain and stiffness in knees 6-4. The score of condition in daily life 6-5. The score of general activities 6-6. The score of health conditions 6-7. Individual items of the JKOM questionnaire 7. MOS Short-Form 36-Item Health Survey (SF-36) 7-1. Physical component summary (PCS) 7-2. Mental component summary (MCS) 7-3. Role/Social component summary (RCS) 7-4. Physical functioning 7-5. Role physical 7-6. Bodily pain 7-7. General health 7-8. Vitality 7-9. Social functioning 7-10. Role emotional 7-11. Mental health 8. The total score of Pittsburgh Sleep Quality Index, Japanese version (PSQI-J) 9. Specific IgE (cedar pollen, cypress pollen, Dermatophagoides pteronyssinus and house dust) * 1-5, 7-9 Assess the measured value at screening (before consumption) and at four weeks after the start of test-food consumption and calculate the amount of change. * 6 Measured at screening (before consumption) and at four weeks after the start of test-food consumption. | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed