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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Native type II collagen | Experimental | Native type II collagen |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Native type II collagen | Dietary Supplement | 1 capsule/day |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Daily activity levels | A fitness tracker will monitor the steps taken daily | Day 0 to 180, anytime |
| Muscle quality | Muscle quality will be evaluated by an ultrasound index |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Poal de ReumatologÃa | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41787523 | Derived | Moller I, Martinez K, Terradillos-Guillen A, Costa-Larrion E, Martinez-Puig D, Velasco-Alvarez J. Efficacy and tolerability of native (undenatured) type II collagen supplementation for joint health in healthy volunteers: a randomized double-blind placebo-controlled study. Nutr J. 2026 Mar 6;25(1):46. doi: 10.1186/s12937-026-01302-0. |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| Placebo |
| Dietary Supplement |
1 capsule/day |
|
| 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 |
| Day 0 and 180 |
| Safety assessment | Adverse events | Day 0 to 180, anytime |
| Safety assessment | Medical exams (weight in kilograms, height in meters, BMI in kg/m^2) | Day 0 to day 60, 90, 120, 180 |
| Safety assessment | Vital signs (heart rate in bpm and blood pressure mmHg) | Day 0 to day 60, 90, 120, 180 |
| Safety assessment | Laboratory analysis (total blood count, glucose, AST, ALT, Cholesterol, Creatinine, BUN, triglycerides, alkaline phosphatase) | Day 0 and 180 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |