Clinical trial NCT05282992: NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Tolerability of a Food Supplement in Healthy Volunteers With Joint Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Pain
Lead sponsor: Bioiberica
Sponsor class: INDUSTRY
First posted: 2022-03-16
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: This study will include 100 healthy volunteers in which will be evaluated if the collagen supplement is able to obtain differences versus placebo in pain and function. It will be a randomized, double-blind, placebo-controlled study with proportion 1:1 between treatments

Eligibility criteria: 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

Primary outcomes:
measure: Change in joint discomfort onset
timeFrame: Change in joint discomfort onset at 6 months
Secondary outcomes:
measure: Joint discomfort
timeFrame: Day 0 to day 60, 90, 120, 180
measure: Joint function
timeFrame: Day 0 to day 60, 90, 120, 180
measure: Time to Joint discomfort
timeFrame: Day 0 to day 60, 90, 120, 180
measure: 6 minute walking timed test (6MWT)
timeFrame: Day 0 and 180
measure: Rescue medication consumption
timeFrame: Day 0 to 180, anytime
measure: Cartilage turnover biomarkers
timeFrame: Day 0 and 180
Other outcomes:
measure: Daily activity levels
timeFrame: Day 0 to 180, anytime
measure: Muscle quality
timeFrame: Day 0 and 180
measure: Safety assessment
timeFrame: Day 0 to 180, anytime
measure: Safety assessment
timeFrame: Day 0 to day 60, 90, 120, 180
measure: Safety assessment
timeFrame: Day 0 to day 60, 90, 120, 180
measure: Safety assessment
timeFrame: Day 0 and 180
Locations:
city: Barcelona
country: Spain
facility: Instituto Poal de Reumatología
Study officials:
References: