Effect of Collavant® n2 in Healthy Male Adults With Exercise-induced Joint Discomfort. (COLLMOTION)
2026年5月11日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
80
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Mónica García-López, Doctor
- 電話番号：+34 93 765 03 90
- メール：monicagarcia@bioiberica.com
研究場所
-
-
Madrid
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Madrid、Madrid、スペイン、28040
- 募集
- Universidad Politécnica de Madrid
-
コンタクト：
- Marcela Gonzalez-Gross, Professor
- 電話番号：(+34) 910677962
- メール：marcela.gonzalez.gross@upm.es
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コンタクト：
- Javier Modrego-Martin, Doctor
- 電話番号：(+34) 910677962
- メール：javier.modrego@upm.es
-
主任研究者：
- Marcela González-Gross, Professor
-
主任研究者：
- Javier Modrego-Martin, Doctor
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：プラセボ
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Placebo. 1 capsule / day
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実験的：Collavant® n2
Native type II collagen (Collavant® n2)
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Native type II collagen (Collavant® n2). 1 capsule 40 mg / day |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Exercise-Induced Knee Joint Discomfort
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in joint pain intensity after physical activity
時間枠：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).
|
Baseline (week 0) to week 12
|
|
Change in joint pain intensity before physical activity
時間枠：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.
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Baseline (week 0) to week 12, baseline (week 0) to week 24
|
|
Time to recovery of knee pain after exercise
時間枠：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.
|
Baseline (week 0) to week 12, baseline (week 0) to week 24
|
|
Change in physical performance during the running test
時間枠：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
時間枠：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
時間枠：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.
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Baseline (week 0) to week 12, baseline (week 0) to week 24
|
|
Change in knee joint inflammation
時間枠：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.
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Baseline (week 0) to week 12, baseline (week 0) to week 24
|
|
Change in cartilage biomarkers
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in clinical knee examination
時間枠：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
時間枠：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.
|
Baseline (week 0) to week 24
|
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Changes in Vital Signs
時間枠：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
時間枠：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
時間枠：Baseline (week 0) to week 24
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Change from baseline in participant-reported physical activity level assessed using IPAQ questionnaire.
|
Baseline (week 0) to week 24
|
|
Change in dietary habits
時間枠：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
時間枠：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
時間枠：Baseline (week 0) to week 24]
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Change from baseline in muscle strength (in Kg or Newtons) assessed by handgrip dynamometry.
|
Baseline (week 0) to week 24]
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Marcela González-Gross, Professor、Universidad Politécnica de Madrid
- 主任研究者：Javier Modrego-Martin, Doctor、Universidad Politécnica de Madrid
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月6日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年3月1日
試験登録日
最初に提出
2026年4月10日
QC基準を満たした最初の提出物
2026年4月24日
最初の投稿 (実際)
2026年5月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月13日
QC基準を満たした最後の更新が送信されました
2026年5月11日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- PJ-00186 / COLLMOTION (その他の識別子：Bioiberica)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。