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NCT Number: NCT07561203

Effect of Collavant® n2 in Healthy 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.

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Key information

Conditions

Healthy Adult Male

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Politecnica de Madrid

Madrid, 28040, Spain

Location status: Recruiting

Location contact

Javier Modrego-Martin, Doctor

CONTACT

[email protected]

(+34) 910677962

Javier Modrego-Martin, Doctor

PRINCIPAL_INVESTIGATOR

Marcela Gonzalez-Gross, Professor

CONTACT

[email protected]

(+34) 910677962

Marcela González-Gross, Professor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Native type II collagen (Collavant® n2)

Dietary Supplement

Native type II collagen (Collavant® n2).

1 capsule 40 mg / day

Placebo

Other

Placebo. 1 capsule / day

Primary outcomes

  1. 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

  1. Change in joint pain intensity after physical activity

    Time frame: Baseline (week 0) to week 12

    Knee pain intensity following the running test will be measured using a Visual Analogue Scale (VAS).

  2. Change in joint pain intensity before physical activity

    Time frame: 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.

  3. Time to recovery of knee pain after exercise

    Time frame: 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.

  4. Change in physical performance during the running test

    Time frame: 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.

  5. Change in perceived exertion during physical activity

    Time frame: 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.

  6. Change in knee joint function

    Time frame: 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.

  7. Change in knee joint inflammation

    Time frame: 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.

  8. Change in cartilage biomarkers

    Time frame: 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.

Other outcomes

  1. Change in clinical knee examination

    Time frame: Baseline (week 0) to week 12, baseline (week 0) to week 24

    Clinical assessment of patellofemoral pain using the Zohlen test will be performed before and after the running test.

  2. Incidence of Adverse Events

    Time frame: Baseline (week 0) to week 24

    Number and percentage of participants experiencing adverse events classified by severity and relationship to the study intervention.

  3. Changes in Vital Signs

    Time frame: Baseline (week 0) to week 24

    Change from baseline in vital signs: systolic and diastolic blood pressure (mmHg) and heart rate (beats per minute).

  4. Changes in clinical laboratory parameters

    Time frame: Baseline (week 0) to week 24

    Change from baseline in clinical laboratory parameters: hematology and blood biochemistry values.

  5. Changes in physical activity level

    Time frame: Baseline (week 0) to week 24

    Change from baseline in participant-reported physical activity level assessed using IPAQ questionnaire.

  6. Change in dietary habits

    Time frame: Baseline (week 0) to week 24

    Change from baseline in participant-reported dietary intake assessed using the Mediterranean Diet Adherence Questionnaire.

  7. Change in Quality of Life score

    Time frame: Baseline (week 0) to week 24

    Change from baseline in quality of life score assessed using the Quality of Life questionnaire SF-12

  8. Change in muscle strength assessed by handgrip dinamometry

    Time frame: Baseline (week 0) to week 24]

    Change from baseline in muscle strength (in Kg or Newtons) assessed by handgrip dynamometry.

Study contacts

Contact information is provided by the study sponsor or research team.

Mónica García-López, Doctor

CONTACT

[email protected]

+34 93 765 03 90

Sponsors and collaborators

Lead sponsor

Bioiberica

Industry

Collaborators

  • Universidad Politecnica de Madrid

Registry information

Official study 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.

Acronym: COLLMOTION

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 1, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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