Collavant n2 for exercise-related knee discomfort in active men
A Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Effect of Collavant® n2 on Joint Function and Performance in Healthy, Active Male Adults With Exercise-induced Joint Discomfort.
This will see if taking 40 mg of Collavant® n2 daily helps reduce knee discomfort and improve joint function in healthy amateur male runners who get knee pain with exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Male |
| Sponsor | Bioiberica Industry-sponsored |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07561203 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled parallel study enrolling 80 healthy amateur male runners aged 40–65 who report exercise-induced knee discomfort. Participants are randomized 1:1 to receive 40 mg/day Collavant® n2 or placebo for 24 weeks with assessments at baseline, 12 weeks, and 24 weeks. The primary outcome is change in joint discomfort, with secondary measures including joint function, physical performance, perceived exertion, pain before exercise, time to pain recovery, and markers of joint inflammation. Safety and tolerability are monitored throughout via adverse event reporting, vitals, physical exams, laboratory tests, and quality-of-life measures.
Who should consider this trial
Good fit: Ideal candidates are healthy male amateur runners aged 40–65 who train at least 150 minutes per week, report persistent exercise-related knee discomfort (≥20 mm VAS), and have no diagnosed knee pathology.
Not a fit: People with diagnosed knee conditions such as osteoarthritis, those who are not regularly physically active, women, or individuals whose knee pain is not triggered by exercise are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, it could reduce exercise-related knee pain and improve joint function and performance in active middle-aged men.
How similar studies have performed: Previous smaller trials of undenatured type II collagen have reported modest improvements in joint pain and function in osteoarthritis and exercise-related discomfort, but results have been mixed and the approach remains under study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Have individual devices to monitor training with GPS * Sign informed consent Exclusion Criteria: * 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 * Treatment with probiotics or antibiotics * Inability to train for the next 24 weeks * Follow a vegan diet
Where this trial is running
Madrid, Madrid
- Universidad Politecnica de Madrid — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Marcela González-Gross, Professor — Universidad Politecnica de Madrid
- Study coordinator: Mónica García-López, Doctor
- Email: monicagarcia@bioiberica.com
- Phone: +34 93 765 03 90
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.