None
Conditions
Interventions
A single and consecutive ingestion for 12 weeks of test food
A single and consecutive ingestion for 12 weeks of placebo food
Sponsors
TTC Co.,Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Males and females at the ages of 40 to 74 (2)Subjects who have knee joint pain
Exclusion criteria
Exclusion criteria: (1)Subjects who are classified into 0 or IV grade on the basis of the KL classification (2)Subjects which knee join pain is weaker than pain in other joints (3)Subjects which JOA category I score are 30-points on both knee join (4)Subjects who are suspected gout attack with hyperuricemia (5)Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain (6)Subjects who have performed arthroplasty or need it (7)Subjects who regularly take health food containing bone, cartilage, joint from three month before the screening test to the end of the study (8)Subjects who regularly take medicine with some exceptions (9)Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test (10)Subjects who get an intense exercise to make excessive load on the joints (11)Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test (12)Subjects who regularly use a cane or supporter (13)Subjects who periodically conduct actions that may affect the evaluation of effectiveness (14)Subjects who are biased in eating habits (15)Subjects who get a diagnosis of malignancy, are under treatment for cardiac disease, renal disease and thyroid dysfunction, and have a history of serious disorder such as hepatic disease (16)Subjects who drink alcohol in large quantities (17)Subjects who have at risk of developing food allergies (18)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (19)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (20)Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period (21)Subjects who intend to become pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Food-derived peptide in blood (plasma levels before and after ingestion, AUC, Cmax) Correlation between food-derived peptide in blood (AUC or Cmax) and JKOM | — |
Secondary
| Measure | Time frame |
|---|---|
| Food-derived peptide in urine JKOM Cartilage marker JOA Joint pain | — |
Countries
Japan
Contacts
Public ContactTakashi Nakagawa
TTC Co.,Ltd Clinical Research Planning Department
Outcome results
None listed