Table 1 Inclusion–exclusion criteria
Inclusion | |
• | Subject must be ≥30 and ≤65 years of age |
• | Body mass index (BMI) must be ≥18 and ≤35 kg/m2 |
• | Knee joint criteria: (1) no knee joint discomfort at rest; (2) must achieve a knee joint discomfort score of at least 5 on an 11-point Likert scale within 10 minutes of initiating the stepmill protocol |
• | Maintain existing food and physical activity patterns throughout the study period |
• | Judged by Investigator to be in general good health on the basis of medical history |
• | Subject understands the study procedures and provides signed informed consent to participate in the study and authorizes the release of relevant health information to the study investigator |
• | Females of child bearing age must agree to use approved birth control methods during the study |
Exclusion | |
• | Subjects with any indicators of arthritis, joint disorders, or history of immune system or autoimmune disorders |
• | Daily use of NSAIDs; however, daily use of 81 mg of aspirin for cardioprotection is allowed |
• | Daily use of anti-inflammatory or omega-3-fatty acid dietary supplements or using supplements to maintain joint health 30 days prior to screening |
• | Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation |
• | Use of any immunosuppressive drugs in the last 12 months (including steroids or biologics) |
• | Glucocorticoid injection or hyaluronic acid injection in affected knee within 3 months prior to enrollment |
• | History of surgery or significant injury to the target joint within 6 months prior to study enrollment, or an anticipated need for surgical or invasive procedure that will be performed during the study |
• | Subjects with a chronic pain syndrome and in the judgment of the Investigator is unlikely to respond to any therapy |
• | Participation in a clinical study with exposure to any non-registered drug product within 30 days prior |
• | Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol |
• | Any significant GI condition that would potentially interfere with the evaluation of the study product |
• | Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorder |
• | Subjects with vascular condition which interferes with ambulation |
• | Known allergy or sensitivity to herbal products, soy or eggs |
• | Vegetarian or Vegan |
• | History or presence of cancer in the prior two years, except for non-melanoma skin cancer. |
• | Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk |
• | Untreated or unstable hypothyroidism, an active eating disorder, or evidence of any neurological disorders |
• | Recent history of (within 12 months) or strong potential for alcohol or substance abuse |
• | Females who are pregnant, lactating, or unwilling to use adequate contraception during the study |