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| ID | Type | Description | Link |
|---|---|---|---|
| PJ-00186 / COLLMOTION | Other Identifier | Bioiberica |
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| Name | Class |
|---|---|
| Universidad Politecnica de Madrid | OTHER |
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The present clinical study has been designed to evaluate the effect of Collavant® n2 at a daily dose of 40 mg on joint function and performance in healthy, amateur male runners with exercise-induced knee discomfort.
The COLLMOTION study is a randomized, double-blind, placebo-controlled, parallel clinical study designed to evaluate the effects of Collavant® n2 on joint function, performance and discomfort in healthy, physically active male adults experiencing exercise-induced knee discomfort.
A total of 80 healthy male amateur runners aged 40 to 65 years are enrolled and randomized in a 1:1 ratio to receive either Collavant® n2 (40 mg/day) or placebo for a total intervention period of 24 weeks. Eligible participants are required to train regularly (≥150 minutes per week), report persistent exercise-related knee discomfort, and meet predefined inclusion and exclusion criteria to ensure the absence of diagnosed knee pathology such as osteoarthritis.
The primary objective of the study is to assess differences from baseline and versus placebo in joint discomfort. Secondary objectives include the evaluation of joint function, physical performance, perceived exertion, pain intensity before exercise, time to pain recovery, and joint inflammation.
Safety and tolerability are evaluated throughout the study via monitoring of adverse events, vital signs, physical examinations, laboratory parameters, and quality-of-life assessments. Participants undergo assessments at baseline, 12 weeks, and 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collavant® n2 | Experimental | Native type II collagen (Collavant® n2) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Native type II collagen (Collavant® n2) | Dietary Supplement | Native type II collagen (Collavant® n2). 1 capsule 40 mg / day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Exercise-Induced Knee Joint Discomfort | Joint discomfort will be assessed using a Visual Analogue Scale (VAS) to quantify knee pain intensity associated with physical activity. The primary endpoint is the change in knee joint discomfort from baseline, comparing Collavant® n2 versus placebo. VAS scores will be collected under standardized conditions after the running test, to capture exercise-induced discomfort. | Baseline (week 0) to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in joint pain intensity after physical activity | Knee pain intensity following the running test will be measured using a Visual Analogue Scale (VAS). | Baseline (week 0) to week 12 |
| Change in joint pain intensity before physical activity |
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinical knee examination | Clinical assessment of patellofemoral pain using the Zohlen test will be performed before and after the running test. | Baseline (week 0) to week 12, baseline (week 0) to week 24 |
| Incidence of Adverse Events |
Inclusion Criteria:
Exclusion Criteria:
Male gender
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mónica García-López, Doctor | Contact | +34 93 765 03 90 | monicagarcia@bioiberica.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcela González-Gross, Professor | Universidad Politecnica de Madrid | Principal Investigator |
| Javier Modrego-Martin, Doctor | Universidad Politecnica de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Politecnica de Madrid | Recruiting | Madrid | Madrid | 28040 | Spain |
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| Placebo | Other | Placebo. 1 capsule / day |
|
Knee pain intensity will be assessed using a Visual Analogue Scale (VAS) prior to performing the standardized running test.
| Baseline (week 0) to week 12, baseline (week 0) to week 24 |
| Time to recovery of knee pain after exercise | The time required for knee pain to return to the participant's pre-exercise baseline level following the running test will be recorded by participant self-report. | Baseline (week 0) to week 12, baseline (week 0) to week 24 |
| Change in physical performance during the running test | Physical performance will be assessed by recording completion time (in seconds) for a standardized running test. | Baseline (week 0) to week 12, baseline (week 0) to week 24 |
| Change in perceived exertion during physical activity | Perceived exertion will be assessed using the Borg Rating of Perceived Exertion (RPE) scale immediately after the running test. | Baseline (week 0) to week 12, baseline (week 0) to week 24 |
| Change in knee joint function | Knee function will be evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS), a validated questionnaire assessing pain, symptoms, activities of daily living, sport/recreation function, and knee-related quality of life. | Baseline (week 0) to week 12, baseline (week 0) to week 24 |
| Change in knee joint inflammation | Thermal response of the knee joint will be evaluated using infrared thermography before exercise, immediately after exercise, and 30 minutes post-exercise to assess exercise-induced inflammatory response. | Baseline (week 0) to week 12, baseline (week 0) to week 24 |
| Change in cartilage biomarkers | Blood and urine biomarkers related to cartilage turnover and inflammation will be measured. | Baseline (week 0) to week 12, baseline (week 0) to week 24 |
Number and percentage of participants experiencing adverse events classified by severity and relationship to the study intervention.
| Baseline (week 0) to week 24 |
| Changes in Vital Signs | Change from baseline in vital signs: systolic and diastolic blood pressure (mmHg) and heart rate (beats per minute). | Baseline (week 0) to week 24 |
| Changes in clinical laboratory parameters | Change from baseline in clinical laboratory parameters: hematology and blood biochemistry values. | Baseline (week 0) to week 24 |
| Changes in physical activity level | Change from baseline in participant-reported physical activity level assessed using IPAQ questionnaire. | Baseline (week 0) to week 24 |
| Change in dietary habits | Change from baseline in participant-reported dietary intake assessed using the Mediterranean Diet Adherence Questionnaire. | Baseline (week 0) to week 24 |
| Change in Quality of Life score | Change from baseline in quality of life score assessed using the Quality of Life questionnaire SF-12 | Baseline (week 0) to week 24 |
| Change in muscle strength assessed by handgrip dinamometry | Change from baseline in muscle strength (in Kg or Newtons) assessed by handgrip dynamometry. | Baseline (week 0) to week 24] |