Clinical trial: Study to Evaluate the Safety and Efficacy of a Proprietary "Joint Health" Dietary Supplement in Subjects With Joint and Connective Tissue Pain (NCT03209895)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects must be able and willing to give Informed Consent.

          -  Subjects must not have taken anti-inflammatory drugs or supplements for 5 days prior
             to their initial C-RP blood test, and must refrain from taking these products for the
             duration of the study.

          -  Subjects will be required to refrain from taking other pain-reducing agents during the
             course of the study. This will ensure that the effects observed in the study are the
             effects of the supplement only, and not of other anti-inflammatory agents

          -  Subjects must have had knee or hip joint or muscle pain on most days of the previous
             month; should not have "morning stiffness" for more than 30 minutes; and should
             experience "stiffness" after resting.

          -  Subjects must have persistent pain in the knee or hip joints or connective tissue with
             a pain assessment score of at least 5, but not more than 9 using the WOMAC Pain
             Assessment and Pain Intensity Rating scale.

          -  Subjects must be available for and willing to attend all evaluation visits.

          -  Subjects must be willing to take/use the test Krill Oil compositions in place of
             current pain relief medications.

          -  Subjects may not be on any steroid-based therapies.

          -  Subjects must have access to a telephone for calling into the Clinical Center as part
             of test product compliance.

          -  Subjects must be willing to use appropriate birth control for duration of trial (if
             appropriate)

          -  Subjects must be willing to limit consumption of fatty fish for one week prior to and
             during the study

          -  Subjects must be willing to refrain from taking any other nutritional supplements
             related to immune function or pain reduction during the course of this study.

        Exclusion Criteria:

          -  Subjects must not be taking remission-inducing drugs such as methotrexate.

          -  Subjects whose joint pain is not in their knees.

          -  Subjects who are not willing to forego the use of anti-inflammatory and anti-pain
             medications or supplements for the duration of the study.

          -  Subjects who know that their joint pain is due to osteoarthritis or rheumatoid
             arthritis.

          -  Women who are pregnant, breastfeeding, or planning to become pregnant during the

          -  course of the trial

          -  Clinical evidence or known history of severe cardiac, pulmonary, gastrointestinal,
             renal, hepatic or neurological disorders.

          -  History of allergy to aspirin or NSAlDs.

          -  Subjects who have undergone total knee replacement in the contra-lateral knee within 6
             months prior to the screening visit.

          -  Subjects who have received an intra-articular corticosteroid injection in a lower
             joint during the three (3) months prior to the baseline visit.

          -  Subjects with isolated lateral compartment disease defined by joint space loss in the
             lateral compartment only.

          -  Subjects who have received chondrocyte transplants in any lower extremity joint.

          -  Subjects with co-morbid conditions that restrict knee function.

          -  Treatment with corticosteroids before washout period

          -  Patients with infectious arthritis or gout

          -  Unstable medical conditions.

          -  Use of omega fatty acid supplements within two weeks of this study

          -  Clinically significant abnormal laboratory results at baseline

          -  Participation in a clinical research trial within 30 days prior to randomization

          -  Allergy, especially from crustaceans, or sensitivity to study supplement ingredients

          -  Individuals cognitively impaired and/or who are unable to give Informed Consent

          -  Any other health or mental condition that in the Investigator's opinion may adversely
             affect the subject's ability to complete the study or its measures or that may pose
             significant risk to the subject

          -  Subjects taking Inflammatory medications, cardiovascular medications, hypotensive
             medications, blood thinners

          -  Presence of auto immune diseases, other diseases of the immune systems,

          -  gastrointestinal diseases, i.e. Irritable bowel syndrome, or disorders of lipid
             metabolism.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 80 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? 1