Healthy Adult MaleCOLLMOTIONNCT07561203
Effect of Collavant® n2 in Healthy Male Adults With Exercise-induced Joint Discomfort.
A study testing Native type II collagen (Collavant® n2) in people with Healthy Adult Male, run by Bioiberica at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- Native type II collagen (Collavant® n2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad Politecnica de Madrid
Madrid, Madrid, 28040
Marcela Gonzalez-Gross, Professor, (+34) 910677962, marcela.gonzalez.gross@upm.es
Javier Modrego-Martin, Doctor, (+34) 910677962, javier.modrego@upm.es
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Healthy Adult Male
- Being tested
- Native type II collagen (Collavant® n2), Placebo
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native type II collagen (Collavant® n2)Dietary supplement
Native type II collagen (Collavant® n2).
1 capsule 40 mg / day
PlaceboOther
Placebo. 1 capsule / day
| Study group | Role | What they receive |
|---|---|---|
| Collavant® n2 | Experimental | Native type II collagen (Collavant® n2) Receives: Dietary Supplement: Native type II collagen (Collavant® n2) |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0) to week 24
Secondary outcomes (8)
Change in joint pain intensity after physical activity
Knee pain intensity following the running test will be measured using a Visual Analogue Scale (VAS).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (week 0) to week 12, baseline (week 0) to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start6 May 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Politecnica de Madrid
- Responsible party
- Sponsor
- Investigators
- Marcela González-Gross, Professor, Principal investigator, Universidad Politecnica de MadridJavier Modrego-Martin, Doctor, Principal investigator, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561203
- Sponsor's protocol ID
- PJ-00186 / COLLMOTION
- Other IDs
- PJ-00186 / COLLMOTION
- Acronym
- COLLMOTION
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07561203
- Acronym / sponsor ID
- COLLMOTION / PJ-00186 / COLLMOTION
- Conditions
- Healthy Adult Male
- Keywords
- Native type II collagen, Undenatured type II collagen, Collavant® n2, Joint discomfort, Knee discomfort, Joint function, Cartilage biomarkers, Healthy active adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- Collaborators
- Universidad Politecnica de Madrid
- Study start
- 6 May 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collavant® n2 | Experimental | Dietary Supplement: Native type II collagen (Collavant® n2)Native type II collagen (Collavant® n2) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Native type II collagen (Collavant® n2)Native type II collagen (Collavant® n2). 1 capsule 40 mg / day | Dietary supplement | Collavant® n2 |
| PlaceboPlacebo. 1 capsule / day | Other | Placebo |
Primary outcome
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.
8 secondary outcomes
Change in joint pain intensity after physical activity
Time frame: Baseline (week 0) to week 12
Change in joint pain intensity before physical activity
Time frame: Baseline (week 0) to week 12, baseline (week 0) to week 24
Time to recovery of knee pain after exercise
Time frame: Baseline (week 0) to week 12, baseline (week 0) to week 24
Change in physical performance during the running test
Time frame: Baseline (week 0) to week 12, baseline (week 0) to week 24
Change in perceived exertion during physical activity
Time frame: Baseline (week 0) to week 12, baseline (week 0) to week 24
Change in knee joint function
Time frame: Baseline (week 0) to week 12, baseline (week 0) to week 24
Change in knee joint inflammation
Time frame: Baseline (week 0) to week 12, baseline (week 0) to week 24
Change in cartilage biomarkers
Time frame: Baseline (week 0) to week 12, baseline (week 0) to week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcela González-Gross, Professor principal investigator
Universidad Politecnica de Madrid
Javier Modrego-Martin, Doctor principal investigator
Universidad Politecnica de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Native type II collagen (Collavant® n2) in people with Healthy Adult Male, run by Bioiberica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mónica García-López, Doctor (+34 93 765 03 90, monicagarcia@bioiberica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exercise-Induced Knee Joint Discomfort (time frame: Baseline (week 0) to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.