- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Kingston upon Thames, Spojené království, KT1 2EE
- Department of Applied and Human Sciences
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: Suplementace placeba
|
Placebo Supplementation
|
|
Experimentální: Ecklonia Cava Supplementation
|
Ecklonia Cava Supplementation
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Peak Power Output During Sprint Performance (Watts)
Časové okno: Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
Peak power output achieved during 20-second maximal sprint efforts performed following a fixed-intensity (55% Wmax) 60-minute cycling protocol
|
Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
|
Mean Power Output During Sprint Performance (Watts)
Časové okno: Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
Mean power output recorded during repeated 20-second maximal sprint efforts following steady-state cycling
|
Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
|
Blood Lactate Concentration During Sprint Cycling (mmol/L)
Časové okno: 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 lactate concentration measured following each repeated sprint efforts (3)
|
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 During Sprint Cycling (mmol/L)
Časové okno: 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
|
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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Heart Rate During Submaximal Cycling (beats per minute)
Časové okno: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation (each condition)
|
Average heart rate measured during a 60-minute steady-state cycling protocol performed at 55% maximal power output
|
During the 60-minute submaximal cycling protocol, 30 minutes after supplementation (each condition)
|
|
Blood Lactate Concentration During Submaximal Cycling (mmol/L)
Časové okno: Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
Blood lactate concentration measured during steady-state cycling at 55% maximal power output
|
Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
|
Blood Glucose Concentration During Submaximal Cycling (mmol/L)
Časové okno: 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
|
Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
|
Oxygen Consumption (VO₂) During Submaximal Cycling (ml/kg/min)
Časové okno: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
Oxygen consumption measured using indirect calorimetry during steady-state cycling
|
During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
|
Respiratory Exchange Ratio (RER) During Submaximal Cycling
Časové okno: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
Respiratory exchange ratio measured during steady-state cycling using expired gas analysis
|
During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1501 (CSL Behring)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .