Nutramax Joint Health Formulation Biochemical Response Study

Inclusion Criteria

• Subject is able to understand and sign the informed consent.
• Subject is willing and able to comply with the protocol.
• Male or female subjects of any race, aged 40 to 64 years
• Subject has a BMI of 24 to 40 kg/m2
• Subject has had pain in one or both knees for a minimum of 15 days within the 30 days prior to the start of the study.
• Subject has had symptoms of knee pain for at least 6 months.
• Subject has been diagnosed within the previous 30 days with moderate to severe knee osteoarthritis - based on attending physician's diagnosis from physical exam in conjunction with Kellgren-Lawrence X-ray grade of ≥ 2 (radiographs taken within previous 30 days must be available to the investigator, or be obtained at the screening visit).
• Subject can walk.
• Before study enrollment, subject routinely uses acetaminophen (at any dose) with a history of therapeutic benefit.
• Subject has a visual analogue scale (VAS) score of ≥ 4 at the initial visit. Subject may continue taking acetaminophen at the screening but will not have taken additional analgesics for at least 48 hours prior to the initial visit.
• Female subject abstains from sexual intercourse, is surgically sterile, post-menopausal, or agrees to use a FDA-approved method of birth control.

Exclusion Criteria

• Subject has any of the following medical conditions:
• active heart disease - defined as currently under the care of a cardiologist
• high blood pressure (≥ 140/90 mmHg)
• renal or hepatic impairment/disease
• Type I or II diabetes
• Bipolar or major depressive disorder or a history of other psychiatric illness requiring hospitalization in the past 6 months.
• Parkinson's disease
• unstable thyroid disease
• immune disorder (such as HIV/AIDS)
• multiple sclerosis or any other autoimmune disorder
• any arthritic condition, other than OA, affecting a joint other than the knee
• acute septic arthritis
• fibromyalgia or other chronic pain syndromes (OA in locations other than knee allowed)
• gout and hyperuricemia
• peptic ulcer disease and/or history of upper gastrointestinal bleeding
• any medical condition deemed exclusionary by the Principal Investigator (PI)
• Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
• Subject has had a significant injury to the target joint within the past 12 months.
• Subject plans to have knee surgery in the next 2 months.
• Subject has had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medication.
• Subject has an allergy to avocados, soybeans, shellfish or any other ingredient in the test product.
• Subject requires additional analgesic or a change from acetaminophen. (Subjects requiring acetaminophen dose adjustments may remain in the study and all such dose and/or schedule changes shall be recorded in the raw data and daily patient diary).
• Subject is currently taking any medication or suffers from a medical condition, deemed to potentially interfere with the objectives of the study as determined by the PI.
• Subject has a history of drug or alcohol abuse in the past 12 months.
• Subject is currently consuming more than 2 standard alcoholic beverages a day. A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.
• Subject does not agree to use a FDA-approved method of birth control or is pregnant, lactating, or planning to become pregnant during the study period.
• Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
• Subject is participating or has participated in another research study within 30 days prior to screening.
• Subject has used, or intends to use, any oral or injectable NSAID (e.g., ketorolac, aspirin, ibuprofen, naproxen, diclofenac, etc.) within 7 days pr