- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Kingston upon Thames, Verenigd Koninkrijk, KT1 2EE
- Department of Applied and Human Sciences
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Placebo-suppletie
|
Placebo Supplementation
|
|
Experimenteel: Ecklonia Cava Supplementation
|
Ecklonia Cava Supplementation
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Peak Power Output During Sprint Performance (Watts)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Heart Rate During Submaximal Cycling (beats per minute)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1501 (CSL Behring)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .