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

11 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Spagna
    • Madrid
      • Madrid, Madrid, Spagna, 28040
        • Reclutamento
        • Universidad Politécnica de Madrid
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Marcela González-Gross, Professor
        • Investigatore principale:
          • Javier Modrego-Martin, Doctor

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Altro: Placebo
Placebo. 1 capsule / day
Sperimentale: Collavant® n2
Native type II collagen (Collavant® n2)
Integratore alimentare: Native type II collagen (Collavant® n2)

Native type II collagen (Collavant® n2).

1 capsule 40 mg / day

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Exercise-Induced Knee Joint Discomfort
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in joint pain intensity after physical activity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in clinical knee examination
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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]

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bioiberica

Collaboratori

Universidad Politecnica de Madrid

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 maggio 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

10 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • PJ-00186 / COLLMOTION (Altro identificatore: Bioiberica)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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