Clinical trial: Nutramax Joint Health Formulation Biochemical Response Study (NCT02614274)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 64 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Contradiction