Effect of Collavant® n2 in Healthy Male Adults With Exercise-induced Joint Discomfort. (COLLMOTION)
2026년 5월 11일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
80
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Mónica García-López, Doctor
- 전화번호: +34 93 765 03 90
- 이메일: monicagarcia@bioiberica.com
연구 장소
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Madrid
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Madrid, Madrid, 스페인, 28040
- 모병
- Universidad Politécnica de Madrid
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연락하다:
- Marcela Gonzalez-Gross, Professor
- 전화번호: (+34) 910677962
- 이메일: marcela.gonzalez.gross@upm.es
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연락하다:
- Javier Modrego-Martin, Doctor
- 전화번호: (+34) 910677962
- 이메일: javier.modrego@upm.es
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수석 연구원:
- Marcela González-Gross, Professor
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수석 연구원:
- Javier Modrego-Martin, Doctor
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 위약
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Placebo. 1 capsule / day
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실험적: Collavant® n2
Native type II collagen (Collavant® n2)
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Native type II collagen (Collavant® n2). 1 capsule 40 mg / day |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Exercise-Induced Knee Joint Discomfort
기간: Baseline (week 0) to week 24
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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.
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Baseline (week 0) to week 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in joint pain intensity after physical activity
기간: Baseline (week 0) to week 12
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Knee pain intensity following the running test will be measured using a Visual Analogue Scale (VAS).
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Baseline (week 0) to week 12
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Change in joint pain intensity before physical activity
기간: Baseline (week 0) to week 12, baseline (week 0) to week 24
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Knee pain intensity will be assessed using a Visual Analogue Scale (VAS) prior to performing the standardized running test.
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Baseline (week 0) to week 12, baseline (week 0) to week 24
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Time to recovery of knee pain after exercise
기간: Baseline (week 0) to week 12, baseline (week 0) to week 24
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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.
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Baseline (week 0) to week 12, baseline (week 0) to week 24
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Change in physical performance during the running test
기간: Baseline (week 0) to week 12, baseline (week 0) to week 24
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Physical performance will be assessed by recording completion time (in seconds) for a standardized running test.
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Baseline (week 0) to week 12, baseline (week 0) to week 24
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Change in perceived exertion during physical activity
기간: Baseline (week 0) to week 12, baseline (week 0) to week 24
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Perceived exertion will be assessed using the Borg Rating of Perceived Exertion (RPE) scale immediately after the running test.
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Baseline (week 0) to week 12, baseline (week 0) to week 24
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Change in knee joint function
기간: Baseline (week 0) to week 12, baseline (week 0) to week 24
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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.
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Baseline (week 0) to week 12, baseline (week 0) to week 24
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Change in knee joint inflammation
기간: Baseline (week 0) to week 12, baseline (week 0) to week 24
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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.
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Baseline (week 0) to week 12, baseline (week 0) to week 24
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Change in cartilage biomarkers
기간: Baseline (week 0) to week 12, baseline (week 0) to week 24
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Blood and urine biomarkers related to cartilage turnover and inflammation will be measured.
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Baseline (week 0) to week 12, baseline (week 0) to week 24
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in clinical knee examination
기간: Baseline (week 0) to week 12, baseline (week 0) to week 24
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Clinical assessment of patellofemoral pain using the Zohlen test will be performed before and after the running test.
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Baseline (week 0) to week 12, baseline (week 0) to week 24
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Incidence of Adverse Events
기간: Baseline (week 0) to week 24
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Number and percentage of participants experiencing adverse events classified by severity and relationship to the study intervention.
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Baseline (week 0) to week 24
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Changes in Vital Signs
기간: Baseline (week 0) to week 24
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Change from baseline in vital signs: systolic and diastolic blood pressure (mmHg) and heart rate (beats per minute).
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Baseline (week 0) to week 24
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Changes in clinical laboratory parameters
기간: Baseline (week 0) to week 24
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Change from baseline in clinical laboratory parameters: hematology and blood biochemistry values.
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Baseline (week 0) to week 24
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Changes in physical activity level
기간: Baseline (week 0) to week 24
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Change from baseline in participant-reported physical activity level assessed using IPAQ questionnaire.
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Baseline (week 0) to week 24
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Change in dietary habits
기간: Baseline (week 0) to week 24
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Change from baseline in participant-reported dietary intake assessed using the Mediterranean Diet Adherence Questionnaire.
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Baseline (week 0) to week 24
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Change in Quality of Life score
기간: Baseline (week 0) to week 24
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Change from baseline in quality of life score assessed using the Quality of Life questionnaire SF-12
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Baseline (week 0) to week 24
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Change in muscle strength assessed by handgrip dinamometry
기간: Baseline (week 0) to week 24]
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Change from baseline in muscle strength (in Kg or Newtons) assessed by handgrip dynamometry.
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Baseline (week 0) to week 24]
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Marcela González-Gross, Professor, Universidad Politécnica de Madrid
- 수석 연구원: Javier Modrego-Martin, Doctor, Universidad Politécnica de Madrid
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 6일
기본 완료 (추정된)
2027년 3월 1일
연구 완료 (추정된)
2027년 3월 1일
연구 등록 날짜
최초 제출
2026년 4월 10일
QC 기준을 충족하는 최초 제출
2026년 4월 24일
처음 게시됨 (실제)
2026년 5월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 11일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- PJ-00186 / COLLMOTION (기타 식별자: Bioiberica)
개별 참가자 데이터(IPD) 계획
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아니요
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아니
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아니
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