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

11. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Spania
    • Madrid
      • Madrid, Madrid, Spania, 28040
        • Rekruttering
        • Universidad Politécnica de Madrid
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Marcela González-Gross, Professor
        • Hovedetterforsker:
          • Javier Modrego-Martin, Doctor

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Annen: Placebo
Placebo. 1 capsule / day
Eksperimentell: Collavant® n2
Native type II collagen (Collavant® n2)
Kosttilskudd: Native type II collagen (Collavant® n2)

Native type II collagen (Collavant® n2).

1 capsule 40 mg / day

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Exercise-Induced Knee Joint Discomfort
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in joint pain intensity after physical activity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in clinical knee examination
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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]

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bioiberica

Samarbeidspartnere

Universidad Politecnica de Madrid

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. mai 2026

Primær fullføring (Antatt)

1. mars 2027

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

10. april 2026

Først innsendt som oppfylte QC-kriteriene

24. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • PJ-00186 / COLLMOTION (Annen identifikator: Bioiberica)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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