Effect of Collavant® n2 in Healthy Male Adults With Exercise-induced Joint Discomfort.
ConditionHealthy Adult Male
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-65
SponsorBioiberica
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy physically active male adults (amateur runners) with exercise-induced joint discomfort, aged between 40 and 65 years
Activity level: Amateur runners who train regularly a minimum of 150 minutes per week, divided into 2 or more sessions per week during at least 3 months. Principally, subjects training for popular running events of 10 Kms.
Joint discomfort after activity: Self-reports target knee discomfort after training by a score of at least 20 mm VAS at screening. Discomfort persistent for at least 2w.
Be willing to refrain from starting any new dietary supplements during the entire study that have any underlying joint benefits (collagen, glucosamine, chondroitin, MSM, Hyaluronic Acid, Turmeric, Natural Eggshell Membrane, Omega-3 fatty acids, PEA, Boswellia,..). If any of these supplements (except collagen) or any other dietary supplement has been taken consistently for at least 6 months prior to enrollment, participants should maintain the same stable intake pattern throughout the 24 week study period.
Disqualifiers
Diagnostic of knee osteoarthritis or any pathology or surgical intervention associated with the knee.
Hypersensitivity to any component of the supplement or the placebo
Chronic treatment with analgesic or anti-inflammatory (NSAIDs and corticosteroids families) drugs
Treatment with any type of collagen supplement
Trial design
Design model
Parallel
Treatments tested in this trial
Native type II collagen (Collavant® n2)
Dietary supplementNative type II collagen (Collavant® n2). 1 capsule 40 mg / day
Placebo
Other interventionPlacebo. 1 capsule / day
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Collavant® n2Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 24Secondary outcomes
1
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 122
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 243
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 244
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 24Other outcomes
1
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 242
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 243
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 244
Changes in clinical laboratory parameters
Change from baseline in clinical laboratory parameters: hematology and blood biochemistry values.
Time frame
Baseline (week 0) to week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bioiberica
Lead sponsor
Universidad Politecnica de Madrid
Collaborator
Source ClinicalTrials.gov