An interventional study of Native type II collagen (Collavant® n2) and Placebo in Healthy Adult Male, sponsored by Bioiberica. Recruiting at 1 site in Spain. Open to male participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Bioiberica · Not applicable, Interventional, and Other
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.
Bioiberica is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Native type II collagen (Collavant® n2)
Dietary Supplement: Native type II collagen (Collavant® n2)
Placebo
Other: Placebo
Native type II collagen (Collavant® n2). 1 capsule 40 mg / day
Placebo. 1 capsule / day
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.
Time frame: Baseline (week 0) to week 24
Change in joint pain intensity after physical activity
Knee pain intensity following the running test will be measured using a Visual Analogue Scale (VAS).
Time frame: Baseline (week 0) to week 12
Change in joint pain intensity before physical activity
Knee pain intensity will be assessed using a Visual Analogue Scale (VAS) prior to performing the standardized running test.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (week 0) to week 12, baseline (week 0) to week 24
Change in clinical knee examination
Clinical assessment of patellofemoral pain using the Zohlen test will be performed before and after the running test.
Time frame: Baseline (week 0) to week 12, baseline (week 0) to week 24
Incidence of Adverse Events
Number and percentage of participants experiencing adverse events classified by severity and relationship to the study intervention.
Time frame: 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).
Time frame: Baseline (week 0) to week 24
Changes in clinical laboratory parameters
Change from baseline in clinical laboratory parameters: hematology and blood biochemistry values.
Time frame: Baseline (week 0) to week 24
Changes in physical activity level
Change from baseline in participant-reported physical activity level assessed using IPAQ questionnaire.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline (week 0) to week 24]
Plan to share: No
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