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Effect of Collavant® n2 in Healthy Male Adults With Exercise-induced Joint Discomfort. (COLLMOTION)

11 de mayo de 2026 actualizado por: Bioiberica

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • España
    • Madrid
      • Madrid, Madrid, España, 28040
        • Reclutamiento
        • Universidad Politécnica de Madrid
        • Contacto:
        • Contacto:
          • Javier Modrego-Martin, Doctor
          • Número de teléfono: (+34) 910677962
          • Correo electrónico: javier.modrego@upm.es
        • Investigador principal:
          • Marcela González-Gross, Professor
        • Investigador principal:
          • Javier Modrego-Martin, Doctor

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Otro: Placebo
Placebo. 1 capsule / day
Experimental: Collavant® n2
Native type II collagen (Collavant® n2)
Suplemento dietético: Native type II collagen (Collavant® n2)

Native type II collagen (Collavant® n2).

1 capsule 40 mg / day

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Exercise-Induced Knee Joint Discomfort
Periodo de tiempo: 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.
Baseline (week 0) to week 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in joint pain intensity after physical activity
Periodo de tiempo: Baseline (week 0) to week 12
Knee pain intensity following the running test will be measured using a Visual Analogue Scale (VAS).
Baseline (week 0) to week 12
Change in joint pain intensity before physical activity
Periodo de tiempo: 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.
Baseline (week 0) to week 12, baseline (week 0) to week 24
Time to recovery of knee pain after exercise
Periodo de tiempo: 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.
Baseline (week 0) to week 12, baseline (week 0) to week 24
Change in physical performance during the running test
Periodo de tiempo: 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.
Baseline (week 0) to week 12, baseline (week 0) to week 24
Change in perceived exertion during physical activity
Periodo de tiempo: 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.
Baseline (week 0) to week 12, baseline (week 0) to week 24
Change in knee joint function
Periodo de tiempo: 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.
Baseline (week 0) to week 12, baseline (week 0) to week 24
Change in knee joint inflammation
Periodo de tiempo: 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.
Baseline (week 0) to week 12, baseline (week 0) to week 24
Change in cartilage biomarkers
Periodo de tiempo: 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.
Baseline (week 0) to week 12, baseline (week 0) to week 24

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in clinical knee examination
Periodo de tiempo: 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.
Baseline (week 0) to week 12, baseline (week 0) to week 24
Incidence of Adverse Events
Periodo de tiempo: Baseline (week 0) to week 24
Number and percentage of participants experiencing adverse events classified by severity and relationship to the study intervention.
Baseline (week 0) to week 24
Changes in Vital Signs
Periodo de tiempo: Baseline (week 0) to week 24
Change from baseline in vital signs: systolic and diastolic blood pressure (mmHg) and heart rate (beats per minute).
Baseline (week 0) to week 24
Changes in clinical laboratory parameters
Periodo de tiempo: Baseline (week 0) to week 24
Change from baseline in clinical laboratory parameters: hematology and blood biochemistry values.
Baseline (week 0) to week 24
Changes in physical activity level
Periodo de tiempo: Baseline (week 0) to week 24
Change from baseline in participant-reported physical activity level assessed using IPAQ questionnaire.
Baseline (week 0) to week 24
Change in dietary habits
Periodo de tiempo: Baseline (week 0) to week 24
Change from baseline in participant-reported dietary intake assessed using the Mediterranean Diet Adherence Questionnaire.
Baseline (week 0) to week 24
Change in Quality of Life score
Periodo de tiempo: Baseline (week 0) to week 24
Change from baseline in quality of life score assessed using the Quality of Life questionnaire SF-12
Baseline (week 0) to week 24
Change in muscle strength assessed by handgrip dinamometry
Periodo de tiempo: Baseline (week 0) to week 24]
Change from baseline in muscle strength (in Kg or Newtons) assessed by handgrip dynamometry.
Baseline (week 0) to week 24]

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Bioiberica

Colaboradores

Universidad Politecnica de Madrid

Investigadores

  • Investigador principal: Marcela González-Gross, Professor, Universidad Politécnica de Madrid
  • Investigador principal: Javier Modrego-Martin, Doctor, Universidad Politécnica de Madrid

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de mayo de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

10 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de abril de 2026

Publicado por primera vez (Actual)

1 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • PJ-00186 / COLLMOTION (Otro identificador: Bioiberica)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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