- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Kingston upon Thames, Regno Unito, KT1 2EE
- Department of Applied and Human Sciences
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore placebo: Integrazione con placebo
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Placebo Supplementation
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Sperimentale: Ecklonia Cava Supplementation
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Ecklonia Cava Supplementation
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Peak Power Output During Sprint Performance (Watts)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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 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.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Heart Rate During Submaximal Cycling (beats per minute)
Lasso di tempo: 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)
Lasso di tempo: 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
|
|
Blood Glucose Concentration During Submaximal Cycling (mmol/L)
Lasso di tempo: Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1501 (CSL Behring)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .