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

11 de maio de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

80

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Espanha
    • Madrid
      • Madrid, Madrid, Espanha, 28040
        • Recrutamento
        • Universidad Politécnica de Madrid
        • Contato:
        • Contato:
        • Investigador principal:
          • Marcela González-Gross, Professor
        • Investigador principal:
          • Javier Modrego-Martin, Doctor

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Outro: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Exercise-Induced Knee Joint Discomfort
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in joint pain intensity after physical activity
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change in clinical knee examination
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

6 de maio de 2026

Conclusão Primária (Estimado)

1 de março de 2027

Conclusão do estudo (Estimado)

1 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

10 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de abril de 2026

Primeira postagem (Real)

1 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de maio de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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