- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07611877
Ecklonia Cava Supplementation and Cycling Performance
Acute Ecklonia Cava Supplementation Fails to Enhance Performance in Trained Cyclists
The goal of this clinical trial (randomised, double-blind, placebo-controlled crossover study) is to investigate whether supplementation with Ecklonia cava, a natural extract derived from brown seaweed, affects exercise performance and physiological responses in trained cyclists.
The main questions it aims to answer are:
Does Ecklonia cava supplementation improve cycling performance, including power output during steady-state exercise and short maximal sprints? Does Ecklonia cava supplementation influence physiological responses to exercise, such as blood glucose, blood lactate, heart rate, and oxygen consumption?
Researchers will compare Ecklonia cava supplementation to a placebo (a look-alike substance with no active ingredients) to determine whether the supplement has any effect on performance or physiological responses.
In this crossover design, all participants will receive both the Ecklonia cava supplement and the placebo on separate occasions, with a washout period between conditions.
Participants will:
Ingest either Ecklonia cava or a placebo 30 minutes before exercise testing Complete a 60-minute cycling protocol at a moderate intensity Perform repeated short-duration maximal sprint efforts following the steady-state exercise Attend laboratory testing sessions under both supplement and placebo conditions Undergo measurements of physiological responses, including blood glucose, blood lactate, heart rate, oxygen consumption, and respiratory exchange ratio Have exercise performance assessed through measures of power output during cycling
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Kingston upon Thames, Royaume-Uni, KT1 2EE
- Department of Applied and Human Sciences
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- experienced in cycling (defined as completing at least four hours of cycle training per week with a minimum of two years of experience)
Exclusion Criteria:
- Smoker
- cardiovascular disease
- anti-hypertensive medication
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Supplémentation placebo
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Placebo Supplementation
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Expérimental: Ecklonia Cava Supplementation
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Ecklonia Cava Supplementation
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Peak Power Output During Sprint Performance (Watts)
Délai: Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Peak power output achieved during 20-second maximal sprint efforts performed following a fixed-intensity (55% Wmax) 60-minute cycling protocol
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Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Mean Power Output During Sprint Performance (Watts)
Délai: Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Mean power output recorded during repeated 20-second maximal sprint efforts following steady-state cycling
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Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Blood Lactate Concentration During Sprint Cycling (mmol/L)
Délai: Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
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Blood lactate concentration measured following each repeated sprint efforts (3)
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Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
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Blood Glucose Concentration During Sprint Cycling (mmol/L)
Délai: Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
|
Blood glucose concentration measured following repeated sprint efforts
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Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Heart Rate During Submaximal Cycling (beats per minute)
Délai: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation (each condition)
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Average heart rate measured during a 60-minute steady-state cycling protocol performed at 55% maximal power output
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During the 60-minute submaximal cycling protocol, 30 minutes after supplementation (each condition)
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Blood Lactate Concentration During Submaximal Cycling (mmol/L)
Délai: Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Blood lactate concentration measured during steady-state cycling at 55% maximal power output
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Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Blood Glucose Concentration During Submaximal Cycling (mmol/L)
Délai: Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Blood glucose concentration measured during steady-state cycling at 55% maximal power output
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Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Oxygen Consumption (VO₂) During Submaximal Cycling (ml/kg/min)
Délai: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Oxygen consumption measured using indirect calorimetry during steady-state cycling
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During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Respiratory Exchange Ratio (RER) During Submaximal Cycling
Délai: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Respiratory exchange ratio measured during steady-state cycling using expired gas analysis
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During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1501 (CSL Behring)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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