Effect of Collavant® n2 in Healthy Male Adults With Exercise-induced Joint Discomfort. (COLLMOTION)
11. maj 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mónica García-López, Doctor
- Telefonnummer: +34 93 765 03 90
- E-mail: monicagarcia@bioiberica.com
Studiesteder
-
-
Madrid
-
Madrid, Madrid, Spanien, 28040
- Rekruttering
- Universidad Politécnica de Madrid
-
Kontakt:
- Marcela Gonzalez-Gross, Professor
- Telefonnummer: (+34) 910677962
- E-mail: marcela.gonzalez.gross@upm.es
-
Kontakt:
- Javier Modrego-Martin, Doctor
- Telefonnummer: (+34) 910677962
- E-mail: javier.modrego@upm.es
-
Ledende efterforsker:
- Marcela González-Gross, Professor
-
Ledende efterforsker:
- Javier Modrego-Martin, Doctor
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Placebo. 1 capsule / day
|
|
Eksperimentel: Collavant® n2
Native type II collagen (Collavant® n2)
|
Native type II collagen (Collavant® n2). 1 capsule 40 mg / day |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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]
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marcela González-Gross, Professor, Universidad Politécnica de Madrid
- Ledende efterforsker: Javier Modrego-Martin, Doctor, Universidad Politécnica de Madrid
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. maj 2026
Primær færdiggørelse (Anslået)
1. marts 2027
Studieafslutning (Anslået)
1. marts 2027
Datoer for studieregistrering
Først indsendt
10. april 2026
Først indsendt, der opfyldte QC-kriterier
24. april 2026
Først opslået (Faktiske)
1. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PJ-00186 / COLLMOTION (Anden identifikator: Bioiberica)
Plan for individuelle deltagerdata (IPD)
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