- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07586839
Effect of a Nutritional Supplement on Muscle Recovery (RECOVER)
7 mai 2026 mis à jour par: Marlou Dirks, Wageningen University
The Role of a Nutritional Formulation Containing Caprylic Acid and Omega 3 Fatty Acids in Promoting Skeletal Muscle Function Recovery to Damaging Exercise in Healthy, Young Volunteers
The aim is to develop a food supplement drink that supports muscle health by combining specific fatty acids, which can positively affect metabolic and inflammation processes that are important for muscle health.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
This study will assess the effects of a vegan nutritional formulation containing caprylic acid and omega-3 fatty acids on recovery from muscle-damaging exercise.
The goal is to determine whether this supplement can mitigate muscle damage, reduce inflammation, and accelerate functional recovery, thereby supporting long-term muscle health and functional independence.
This research has the potential to reveal a novel approach to muscle health management, contributing to the development of safe and effective nutritional strategies that support healthy aging.
Type d'étude
Interventionnel
Inscription (Estimé)
28
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Silvie Timmers, PhD
- Numéro de téléphone: +31 317-484 136
- E-mail: silvie.timmers@wur.nl
Lieux d'étude
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Gelderland
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Wageningen, Gelderland, Pays-Bas, 6708WD
- Recrutement
- Wageningen University and Research
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Contact:
- Human and Animal Physiology
- Numéro de téléphone: +31317484136
- E-mail: office.hap@wur.nl
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Young (≥18 and ≤35 years)
- Male sex
- Non-obese (≥18.5 and ≤27.5 kg/m2)
- Recreationally active (performing non-competitive exercise at least one time a week for minimally 30 minutes)
Exclusion Criteria:
- Smoking
- Participation in structural exercise with a major eccentric component (e.g. soccer, basketball, trail running, etc…)
- Chronic use of any prescribed over the counter pharmaceuticals
- Any history of medical or surgical events that may effect the study outcomes
- Following a specific diet (e.g. weight loss, ketogenic, vegan)
- Taking protein supplements
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Testdrink
Drink containing caprylic acid and omega-3 fatty acids
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Seven day supplementation with a muscle damaging exercise performed on day four
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Comparateur placebo: Control drink
Control drink that differs in fatty acid composition
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Seven day supplementation with a muscle damaging exercise performed on day four
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in isometric muscle strength of the vastus lateralis muscle on a muscle dynamometer before and 72h after damaging exercise
Délai: The change in muscle strength will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
|
The main study endpoint is the change in skeletal muscle function recovery from a single bout of damaging eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, from before exercise (t=0) to 72 hours post-exercise.
Skeletal muscle function will be measured as maximal voluntary isometric muscle strength of the vastus lateralis muscle on a muscle dynamometer.
The maximal voluntary strength is expressed as maximal voluntary contraction (Newtons).
|
The change in muscle strength will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in muscle fatigue from before until 72 hours after damaging exercise measured with electrical stimulation on a muscle dynamometer
Délai: The change in fatigue resistance will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
|
The change in muscle fatigue recovery from a single bout of damaging eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids compared to a control emulsion will be examined by means of a two-minute fatigue inducing protocol on a skeletal muscle dynamometer.
Every other second during two minutes, electrically induced muscle contractions will be evoked on the vastus lateralis muscle at 40% of the maximal voluntary muscle strength.
The percental decline in muscle force (N) generating capacity will be monitored as indicator of fatigue resistance.
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The change in fatigue resistance will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Change in muscle soreness from before until up to 72 hours after a damaging exercise using a VAS-Scale and soreness questionnaire
Délai: The change in muscle soreness will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in muscle soreness from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion will be measured by means of a VAS-Scale, measuring current muscle soreness, as well as a retrospective pain questionnaire, measuring muscle soreness over the preceding 24 hours.
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The change in muscle soreness will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma creatine kinase concentrations before and up to 72 hours after damaging exercise in blood
Délai: The change in plasma creatine kinase will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in creatine kinase concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits.
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The change in plasma creatine kinase will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma cholesterol concentrations before and up to 72 hours after damaging exercise in blood
Délai: The change in plasma cholesterol concentrations will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in plasma cholesterol concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits
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The change in plasma cholesterol concentrations will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma triglyceride concentrations before and up to 72 hours after damaging exercise in blood
Délai: The change in plasma triglycerides will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in plasma triglyceride concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits.
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The change in plasma triglycerides will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Plasma beta-hydroxybutyrate concentrations before and up to 72 hours after damaging exercise in blood
Délai: The change in plasma beta-hydroxybutyrate will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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The change in plasma beta-hydroxybutyrate concentrations from a single bout of eccentric exercise between an emulsion containing caprylic acid and omega 3 fatty acids, compared to a control emulsion, will be measured using commercially available kits.
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The change in plasma beta-hydroxybutyrate will be measured at time points 0 hours (before exercise), and post exercise, and at 24 hours, 48 hours and 72 hours post exercise.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
26 septembre 2025
Achèvement primaire (Estimé)
1 juin 2026
Achèvement de l'étude (Estimé)
1 septembre 2026
Dates d'inscription aux études
Première soumission
21 février 2025
Première soumission répondant aux critères de contrôle qualité
7 mai 2026
Première publication (Réel)
14 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NL88300.028.24
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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