NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort

Study Overview
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Brief Summary
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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
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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

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Tolerability of a Food Supplement in Healthy Volunteers With Joint Discomfort

Conditions
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Joint Pain

Intervention / Treatment
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* Dietary Supplement: Native type II collagen
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Native type II collagen<br>Native type II collagen | Dietary Supplement: Native type II collagen<br>* 1 capsule/day<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* 1 capsule/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in joint discomfort onset | Determine differences from baseline on reaching a joint pain of 5/1 while going up and down stairs (max 10 min). | Change in joint discomfort onset at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint discomfort | Visual Analog Scale (VAS, 0-10cm) pain at rest and during activity. A higher VAS means higher pain levels | Day 0 to day 60, 90, 120, 180 | 
| Joint function | Knee injury and Osteoarthritis Outcome Score (KOOS) test | Day 0 to day 60, 90, 120, 180 | 
| Time to Joint discomfort | Time to joint discomfort and to recover from pain in 3 different exercises | Day 0 to day 60, 90, 120, 180 | 
| 6 minute walking timed test (6MWT) | Distance a person is capable of walking on a flat, hard surface in 6 minutes | Day 0 and 180 | 
| Rescue medication consumption | Rescue medication: Paracetamol 500mg. max 2 pills/day | Day 0 to 180, anytime | 
| Cartilage turnover biomarkers | Cartilage turnover biomarkers will be measured in blood and urine (CTX-II, C2C, CPII) | Day 0 and 180 |