- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kingston upon Thames, United Kingdom, KT1 2EE
- Department of Applied and Human Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo Supplementation
|
Placebo Supplementation
|
|
Experimental: Ecklonia Cava Supplementation
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Ecklonia Cava Supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Power Output During Sprint Performance (Watts)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate During Submaximal Cycling (beats per minute)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1501 (CSL Behring)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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