- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Kingston upon Thames, Storbritannia, KT1 2EE
- Department of Applied and Human Sciences
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo-tilskudd
|
Placebo Supplementation
|
|
Eksperimentell: Ecklonia Cava Supplementation
|
Ecklonia Cava Supplementation
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Peak Power Output During Sprint Performance (Watts)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Heart Rate During Submaximal Cycling (beats per minute)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1501 (CSL Behring)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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