- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07501806
Effect of the Combination of Nitrate and Caffeine on Critical Power In Trained Male Cyclists (BEET)
Study Overview
Status
Intervention / Treatment
Detailed Description
Dietary nitrate and caffeine are among the most commonly used ergogenic aids in endurance and high-intensity exercise. Nitrate supplementation has been shown to improve exercise efficiency and tolerance to severe-intensity work, potentially through enhanced nitric oxide availability and improved oxygen delivery and utilization. Caffeine, primarily acting through central nervous system stimulation, has been associated with reduced perceived exertion and enhanced performance across a range of exercise modalities. Despite substantial evidence supporting their independent effects, limited research has examined the combined impact of nitrate and caffeine supplementation on exercise performance.
The present study aims to investigate both the independent and combined effects of acute dietary nitrate and caffeine supplementation on performance outcomes derived from a 3-minute all-out cycling test (3MT), a validated method for estimating critical power and W'. Trained male cyclists will complete four experimental trials in a randomized, double-blind, placebo-controlled, crossover design. Experimental conditions include nitrate-rich beetroot juice with caffeine (BR + CAF), nitrate-rich beetroot juice with placebo (BR), nitrate-depleted beetroot juice with caffeine (CAF), and nitrate-depleted beetroot juice with placebo (PLA).
Participants will consume dietary nitrate 3 hours prior to exercise and caffeine (5 mg/kg body mass) 60 minutes prior to testing. Following a standardized protocol, participants will perform a 3-minute all-out cycling test on an electronically braked cycle ergometer. Primary outcome measures include end power (EP) and work performed above end power (WEP), with secondary outcomes including peak power, mean power, and time-specific power output.
This study aims to determine whether co-ingestion of nitrate and caffeine produces additive or synergistic effects on severe-intensity exercise performance, and to evaluate the extent to which these commonly used ergogenic aids influence performance outcomes associated with critical power in trained individuals.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Charles, Missouri, United States, 63301
- Exercise and Performance Nutrition Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males between the ages of 18 and 40 years of age
- All participants must be trained cyclists, having participated in structured cycling training consisting of at least 2-3 sessions per week for at least 30-60 min each session during the past 12 months.
- All participants must possess a relative max power output (Wmax) of 4.0 W/kg or greater OR a maximal oxygen consumption (VO2max) of 50 ml/kg/min.
- All participants must be healthy and free of any disease as determined through the completion of a medical history questionnaire.
- Body mass index (BMI) between 18.5 - 30 kg/m^2 OR bodyfat percentage <30%
Exclusion Criteria:
- All females
- Males who are younger than 18 years and older than 40 years of age
- Individuals who have a VO2max below 50 ml/kg/min and a relative Wmax below 4.0 W/kg
- Individuals who fail to meet the minimum training requirements of 2-3 sessions per week of structured cycling training for at least 30-60 min per session during the past 12 months.
- Any individual currently diagnosed with or being treated for any cardiovascular, renal, pulmonary, orthopedic, immunological, psychological or musculoskeletal disorder.
- Any individual who is currently supplementing with a known or purported ergogenic aid (nitrates, caffeine, beta-alanine, bicarbonate, creative, Cordyceps) will be required to refrain from their use for 30 days before beginning the study.
- Individuals who regularly smoke or have quit smoking within the last 6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nitrate + Caffeine (BR + CAF)
Participants consume nitrate-rich beetroot juice 3 hours prior to exercise and caffeine 60 minutes prior to exercise.
|
Participants consume concentrated nitrate-rich beetroot juice providing approximately 8.2 mmol of nitrate 3 hours prior to exercise.
Participants consume caffeine at a dose of 5 mg/kg body mass in capsule form 60 minutes prior to exercise.
|
|
Experimental: Nitrate Only (BR)
Participants consume nitrate-rich beetroot juice 3 hours prior to exercise and placebo capsule 60 minutes prior to exercise.
|
Participants consume concentrated nitrate-rich beetroot juice providing approximately 8.2 mmol of nitrate 3 hours prior to exercise.
Participants consume a nitrate-depleted beetroot juice placebo approximately 2-3 hours prior to exercise and a placebo capsule (maltodextrin) approximately 60 minutes prior to exercise.
|
|
Experimental: Caffeine Only (CAF)
Participants consume nitrate-depleted placebo 3 hours prior to exercise and caffeine 60 minutes prior to exercise.
|
Participants consume caffeine at a dose of 5 mg/kg body mass in capsule form 60 minutes prior to exercise.
Participants consume a nitrate-depleted beetroot juice placebo approximately 2-3 hours prior to exercise and a placebo capsule (maltodextrin) approximately 60 minutes prior to exercise.
|
|
Placebo Comparator: Placebo (PLA)
Participants consume nitrate-depleted placebo 3 hours prior to exercise and placebo 60 minutes prior to exercise
|
Participants consume a nitrate-depleted beetroot juice placebo approximately 2-3 hours prior to exercise and a placebo capsule (maltodextrin) approximately 60 minutes prior to exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
End Power
Time Frame: Assessed during a single 3-minute all-out cycling test, approximately 3 hours following supplementation
|
End power (EP) will be determined as the average power output over the final 30 seconds of the 3-minute all-out cycling test and will be used as a surrogate measure of critical power.
|
Assessed during a single 3-minute all-out cycling test, approximately 3 hours following supplementation
|
|
Work Above End Power
Time Frame: Assessed during a single 3-minute all-out cycling test, approximately 3 hours following supplementation
|
Work performed above end power (WEP) will be calculated as the total work completed above EP during the 3-minute all-out cycling test and will be used as a surrogate measure of W' (anaerobic work capacity).
|
Assessed during a single 3-minute all-out cycling test, approximately 3 hours following supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Power Output
Time Frame: Assessed during a single 3-minute all-out cycling test, approximately 3 hours following supplementation
|
Peak power output will be defined as the highest instantaneous power output achieved during the 3-minute all-out cycling test.
|
Assessed during a single 3-minute all-out cycling test, approximately 3 hours following supplementation
|
|
Mean Power Output
Time Frame: Assessed during a single 3-minute all-out cycling test, approximately 3 hours following supplementation
|
Mean power output will be calculated as the average power output across the entire 3-min all-out cycling test.
|
Assessed during a single 3-minute all-out cycling test, approximately 3 hours following supplementation
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-20-170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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