NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort (ACTIVE)

This is an interventional other trial for Joint Pain Read More

Inclusion Criteria:

• Males and non-pregnant females 30-65 years old with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2. (see Section 4.0)
• Unilateral or bilateral knee discomfort for greater than 3 months.
• VAS score during knee movement between 30-50 mm after 7-day withdrawal of excluded medications.
• Reach joint discomfort of 5/10 on a 11-point Likert scale ( score 0 to 10) within 10 minutes of going up and down stairs.
• Clinical laboratory results that are within normal range or considered not clinically significant by the Principal Investigator.
• Be willing to participate in all scheduled visits, tests, and other trial procedures according to the clinical protocol. To do so and be able of using the fitness tracker, a phone or tablet compatible with the Fitbit app is required. (Apple iOS 12.2 or higher, Android OS 7.0 or higher.)
• Be willing to refrain from taking ibuprofen, aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), or any other pain reliever (OTC (Over the Counter) or prescription) during the entire study other than acetaminophen (paracetamol) as rescue medication.
• Provide a signed and dated informed consent indicating that the subject has been informed of all pertinent aspects and possible risks associated with participation in the study.
• Be willing to refrain from taking dietary supplements during the entire study that have any underlying joint benefit (collagen, glucosamine, chondroitin, MSM, Hyaluronic Acid, Turmeric, Natural Eggshell Membrane, Omega-3 fatty acids, PEA, Boswellia,…)

Exclusion Criteria:

• History of hypersensitivity to the rescue medication or any of the products used in the study.
• Requirement of drugs to control joint discomfort.
• Regular drug intake to control any kind of pain.
• History of hypersensitivity to eggs, chicken, or fowl.
• History of Knee OA (OsteoArthritis), inflammatory arthropathy, RA (Rheumatoid Arthritis), OA (VAS score greater than 50), or Systemic Lupus Erythematosus.
• Hyperuricemia (>440 μmol/L), history of gout, or both.
• Exercising (intentionally) for more than 10 hours a week
• High intensity exercise for more than 5 hours a week
• Anticipation of surgery within the next 6 months.
• Recent injury in the target knee (past 4 months).
• History of congestive heart failure.
• Anticipated problems with product consumption.
• Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies within the last 5 years.
• High alcohol intake (>2 standard drinks per day) or use of recreational drugs (e.g., cocaine, methamphetamine, marijuana, etc.).
• Females who are pregnant or lactating or planning to become pregnant.
• History of any mental illness that might impair the ability of subjects to provide a written informed consent.
• Use of oral corticosteroid, indomethacin, SYSADOAs (symptomatic slow action drug osteoarthritis) within 3 months of Visit 1; topical treatment with corticosteroids within 1 week of visit 1, and consumption of Omega 3 fatty acids or any other joint health dietary supplements within 2 weeks preceding the treatment period.
• Consumed, ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription), or any natural health product, (excluding vitamins) within 7 days of first visit.
• Consumed acetaminophen (paracetamol) within 48 hours of randomization visit.
• Participation in any clinical trials within 30 days prior to first visit.
• Individuals following an energy restricted diet for weight loss