Heslthy volunteer
Conditions
Interventions
Continuous intake of the test food product for 12 weeks.
Continuous intake of the placebo food product for 12 weeks.
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and Japanese females aged over 40 and below 75. 2.Presence of discomfort in knee joints. 3.Grade 0 to I in categories K to L in the X-ray examination during selection. 4.Score of 25 or lower on the JOA evaluation of "pain and walking ability" during selection.
Exclusion criteria
Exclusion criteria: 1.Currently seeing a doctor for treatment of a knee joint pain. 2.Currently in treatment with medication. 3.Diagnosed with Hyperuricemia with possible occurrence of a gout attack. 4.Diagnosed with severe disorders such as diabetes, a circulatory disease, a hepatic disease, a renal disease and a cardiac disease, or previous history of any of those. 5.Positive result in a rheumatoid factor test prior to the intake or a possibility of gaining a pain caused by rheumatism. 6.Prior history of a knee surgery or necessity of a knee surgery. 7.Plan to undergo medical treatment on knees during a study period. 8.Underwent a hyaluronic acid injection within two weeks before the selection or a steroid injection within three months before the selection. 9.Diagnosed with bone or joint-related diseases such as a fracture and a sprain within the past three months. 10.Regular intake of health food that contains hyaluronic acid, glucosamine, chondroitin sulfuric acid, quercetin glycoside, vitamin D, or an amino-acid drug, and the intention of consuming the health food during the study period. 11.Regular intake of a pharmaceutical product with an influence on the evaluation of the study (particularly, a pharmaceutical product that contains glucosamine, chondroitin sulfuric acid, vitamin D or an amino-acid drug, or a pharmaceutical product for treatment of osteoporosis). 12.Regular use of a cane. 13.Regular intake of warfarin (product names: Warfarin, Warin, Arefarin, Warfarin K, etc.). 14.Allergic reaction to a food product or a drug. 15.Having the potential to become pregnant during the study or currently pregnant (including a possibility of being pregnant) or nursing. 16.Determined by the investigator or the subinvestigator to be unsuitable for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JOA JKOM VAS hs-CRP | — |
Countries
Japan
Contacts
Public ContactYoshitada Hira
HUMA R&D CORP Clinical Development Division
Outcome results
None listed