Healthy Adult Male
Conditions
Keywords
Native type II collagen, Undenatured type II collagen, Collavant® n2, Joint discomfort, Knee discomfort, Joint function, Cartilage biomarkers, Healthy active adults, Amateur runners, Knee function, Exercise-induced joint discomfort
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.
Interventions
DIETARY_SUPPLEMENTNative type II collagen (Collavant® n2)
Native type II collagen (Collavant® n2). 1 capsule 40 mg / day
OTHERPlacebo
Placebo. 1 capsule / day
Sponsors
Bioiberica
Universidad Politecnica de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exercise-Induced Knee Joint Discomfort | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in joint pain intensity after physical activity | Baseline (week 0) to week 12 | Knee pain intensity following the running test will be measured using a Visual Analogue Scale (VAS). |
| Change in joint pain intensity before physical activity | Baseline (week 0) to week 12, baseline (week 0) to week 24 | Knee pain intensity will be assessed using a Visual Analogue Scale (VAS) prior to performing the standardized running test. |
| Time to recovery of knee pain after exercise | Baseline (week 0) to week 12, baseline (week 0) to week 24 | 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. |
| Change in physical performance during the running test | Baseline (week 0) to week 12, baseline (week 0) to week 24 | Physical performance will be assessed by recording completion time (in seconds) for a standardized running test. |
| Change in perceived exertion during physical activity | Baseline (week 0) to week 12, baseline (week 0) to week 24 | Perceived exertion will be assessed using the Borg Rating of Perceived Exertion (RPE) scale immediately after the running test. |
| Change in knee joint function | Baseline (week 0) to week 12, baseline (week 0) to week 24 | 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. |
| Change in knee joint inflammation | Baseline (week 0) to week 12, baseline (week 0) to week 24 | 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. |
| Change in cartilage biomarkers | Baseline (week 0) to week 12, baseline (week 0) to week 24 | Blood and urine biomarkers related to cartilage turnover and inflammation will be measured. |
Countries
Spain
Contacts
CONTACTMónica García-López, Doctor
PRINCIPAL_INVESTIGATORMarcela González-Gross, Professor
Universidad Politecnica de Madrid
PRINCIPAL_INVESTIGATORJavier Modrego-Martin, Doctor
Universidad Politecnica de Madrid
Outcome results
None listed