NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort (NCT05282992) | Clinical Trial Compass
CompletedNot Applicable
NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort
Spain75 participantsStarted 2022-03-03
Plain-language summary
Collagen Supplement is a natural ingredient that contains native collagen derived from chicken sternum. Collagen Supplement is efficacious and safe on healthy subjects as compared to placebo.
Who can participate
Age range30 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, Natur…
What they're measuring
1
Change in joint discomfort onset
Timeframe: Change in joint discomfort onset at 6 months