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.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Bioiberica
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in Exercise-Induced Knee Joint Discomfort
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Collavant® n2
Native type II collagen (Collavant® n2)
Intervention: Native type II collagen (Collavant® n2) (Dietary Supplement)
Placebo
Placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change in Exercise-Induced Knee Joint Discomfort
Time Frame: Baseline (week 0) to week 24
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.
Secondary Outcomes
- Change in joint pain intensity after physical activity(Baseline (week 0) to week 12)
- Change in joint pain intensity before physical activity(Baseline (week 0) to week 12, baseline (week 0) to week 24)
- Time to recovery of knee pain after exercise(Baseline (week 0) to week 12, baseline (week 0) to week 24)
- Change in physical performance during the running test(Baseline (week 0) to week 12, baseline (week 0) to week 24)
- Change in perceived exertion during physical activity(Baseline (week 0) to week 12, baseline (week 0) to week 24)
- Change in knee joint function(Baseline (week 0) to week 12, baseline (week 0) to week 24)
- Change in knee joint inflammation(Baseline (week 0) to week 12, baseline (week 0) to week 24)
- Change in cartilage biomarkers(Baseline (week 0) to week 12, baseline (week 0) to week 24)