NCT07501806

Brief Summary

This study is investigating the independent and combined effects of acute dietary nitrate and caffeine supplementation on performance during a 3-minute all-out cycling test in trained male cyclists. In a randomized, double-blind, placebo-controlled, crossover design, participants will complete four experimental conditions: nitrate, caffeine, nitrate plus caffeine, and placebo. Primary outcomes include end power (EP) and work done above end power (WEP), surrogate measures of critical power and W'. The study aims to determine whether combined supplementation provides additive benefits for severe-intensity exercise performance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2021

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 19, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

dietary nitratecaffeinebeetroot juicecritical power,cyclingexercise physiologyergogenic aids

Outcome Measures

Primary Outcomes (2)

  • End Power

    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

    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 Outcomes (2)

  • Peak Power Output

    Assessed during a single 3-minute all-out cycling test, approximately 3 hours following supplementation

  • Mean Power Output

    Assessed during a single 3-minute all-out cycling test, approximately 3 hours following supplementation

Study Arms (4)

Nitrate + Caffeine (BR + CAF)

EXPERIMENTAL

Participants consume nitrate-rich beetroot juice 3 hours prior to exercise and caffeine 60 minutes prior to exercise.

Dietary Supplement: Dietary NitrateDietary Supplement: Caffeine

Nitrate Only (BR)

EXPERIMENTAL

Participants consume nitrate-rich beetroot juice 3 hours prior to exercise and placebo capsule 60 minutes prior to exercise.

Dietary Supplement: Dietary NitrateOther: Placebo

Caffeine Only (CAF)

EXPERIMENTAL

Participants consume nitrate-depleted placebo 3 hours prior to exercise and caffeine 60 minutes prior to exercise.

Dietary Supplement: CaffeineOther: Placebo

Placebo (PLA)

PLACEBO COMPARATOR

Participants consume nitrate-depleted placebo 3 hours prior to exercise and placebo 60 minutes prior to exercise

Other: Placebo

Interventions

Dietary NitrateDIETARY_SUPPLEMENT

Participants consume concentrated nitrate-rich beetroot juice providing approximately 8.2 mmol of nitrate 3 hours prior to exercise.

Nitrate + Caffeine (BR + CAF)Nitrate Only (BR)
CaffeineDIETARY_SUPPLEMENT

Participants consume caffeine at a dose of 5 mg/kg body mass in capsule form 60 minutes prior to exercise.

Caffeine Only (CAF)Nitrate + Caffeine (BR + CAF)
PlaceboOTHER

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.

Caffeine Only (CAF)Nitrate Only (BR)Placebo (PLA)

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This study uses a randomized, double-blind, placebo-controlled, crossover design in which each participant completes four experimental conditions: nitrate supplementation (BR), caffeine supplementation (CAF), combined nitrate and caffeine supplementation (BR + CAF), and placebo (PLA). The order of conditions is randomized for each participant, and all participants complete all conditions with a washout period of at least 72 hours between trials.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 30, 2026

Study Start

November 17, 2020

Primary Completion

November 11, 2021

Study Completion

November 11, 2021

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations