Nutramax Joint Health Formulation Biochemical Response Study

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee, pain, osteoarthritis, nutraceutical, nutrition, supplement, non-surgical, biomarker, joint health Read More

Inclusion Criteria:

1. Subject is able to understand and sign the informed consent.
2. Subject is willing and able to comply with the protocol.
3. Male or female subjects of any race, aged 40 to 64 years
4. Subject has a BMI of 24 to 40 kg/m2
5. 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.
6. Subject has had symptoms of knee pain for at least 6 months.
7. 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).
8. Subject can walk.
9. Before study enrollment, subject routinely uses acetaminophen (at any dose) with a history of therapeutic benefit.
10. 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.
11. Female subject abstains from sexual intercourse, is surgically sterile, post-menopausal, or agrees to use a FDA-approved method of birth control.

Exclusion Criteria:

1. Subject has any of the following medical conditions:

   1. active heart disease - defined as currently under the care of a cardiologist
   2. high blood pressure (≥ 140/90 mmHg)
   3. renal or hepatic impairment/disease
   4. Type I or II diabetes
   5. Bipolar or major depressive disorder or a history of other psychiatric illness requiring hospitalization in the past 6 months.
   6. Parkinson's disease
   7. unstable thyroid disease
   8. immune disorder (such as HIV/AIDS)
   9. multiple sclerosis or any other autoimmune disorder
   10. any arthritic condition, other than OA, affecting a joint other than the knee
   11. acute septic arthritis
   12. fibromyalgia or other chronic pain syndromes (OA in locations other than knee allowed)
   13. gout and hyperuricemia
   14. peptic ulcer disease and/or history of upper gastrointestinal bleeding
   15. any medical condition deemed exclusionary by the Principal Investigator (PI)
2. Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
3. Subject has had a significant injury to the target joint within the past 12 months.
4. Subject plans to have knee surgery in the next 2 months.
5. Subject has had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medication.
6. Subject has an allergy to avocados, soybeans, shellfish or any other ingredient in the test product.
7. 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).
8. 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.
9. Subject has a history of drug or alcohol abuse in the past 12 months.
10. 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.
11. 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.
12. 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.
13. Subject is participating or has participated in another research study within 30 days prior to screening.
14. Subject has used, or intends to use, any oral or injectable NSAID (e.g., ketorolac, aspirin, ibuprofen, naproxen, diclofenac, etc.) within 7 days prior to screening through study completion.
15. Subject has been treated with oral corticosteroids within 4 weeks prior to screening.
16. Subject had intra-articular corticosteroids in the target joint within 3 months prior to screening.
17. Subjects may not take any dietary, vitamin, mineral, or herbal supplements within 7 days prior to Day 0 through study completion. For subjects taking such products at time of the initial visit, a seven-day washout period prior to study Day 1 is allowed EXCEPT for joint health/anti-inflammatory products (see # 18).
18. Subjects who are currently taking or have taken for ≥ 30 consecutive days OR ≥ 60 days total, within the 180 days prior to screening, dietary products intended to decrease inflammation, body pain and/or improve joint health; including, but not necessarily limited to, glucosamine, chondroitin, avocado-soybean unsaponifiable (ASU), and methylsulfonylmethane (MSM) shall be excluded from the study.