NCT07735455

Brief Summary

Background: Dietary nitrate is a natural compound found in vegetables such as beetroot and leafy greens. Previous research suggests that consuming nitrate before exercise may improve endurance and physical performance. However, it is still unclear whether higher doses provide greater benefits, particularly in recreationally trained individuals. Purpose: This study aimed to investigate whether different doses of dietary nitrate taken before exercise influence endurance performance and muscle fatigue during a running test in recreationally trained men. Methods: This randomized, double-blind, placebo-controlled crossover pilot study compared the effects of a placebo and three different doses of dietary nitrate consumed before exercise. On separate occasions, participants completed the same treadmill running test to exhaustion after ingesting the assigned supplement. Measures of muscle performance, blood lactate concentration, and perceived exertion were collected before and after exercise to evaluate the effects of dietary nitrate supplementation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

beetroot juiceexercise tolerancemuscle powerrecreational athletesacute supplementation

Outcome Measures

Primary Outcomes (1)

  • Time to Exhaustion (TTE)

    Time to exhaustion during a constant-speed treadmill running test performed at the speed corresponding to the second ventilatory threshold (VT2). Time was recorded in seconds from the start of the test until volitional exhaustion.

    Baseline (single exercise session, approximately 2.5 hours after supplementation)

Secondary Outcomes (5)

  • Countermovement Jump (CMJ) Height

    Immediately before supplementation exercise and immediately after exercise

  • Drop Jump (DJ) Height

    Immediately before exercise and immediately after exercise

  • Isometric Deadlift Peak Force

    Immediately before supplementation and immediately after exercise

  • Blood Lactate Concentration

    Immediately before exercise and immediately after exercise

  • Rating of Perceived Exertion (RPE)

    Immediately after exercise

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants receive placebo before exercise.

Other: Placebo

4.8 mmol Dietary Nitrate

EXPERIMENTAL

Participants receive 4.8 mmol dietary nitrate before exercise.

Dietary Supplement: Dietary Nitrate

8.1 mmol Dietary Nitrate

EXPERIMENTAL

Participants receive 8.1 mmol dietary nitrate before exercise.

Dietary Supplement: Dietary Nitrate

11.3 mmol Dietary Nitrate

EXPERIMENTAL

Participants receive 11.3 mmol dietary nitrate before exercise.

Dietary Supplement: Dietary Nitrate

Interventions

Dietary NitrateDIETARY_SUPPLEMENT

Participants received a single acute dose of dietary nitrate before exercise. Three doses were evaluated (4.8 mmol, 8.1 mmol, and 11.3 mmol), administered approximately 2.5 hours before the treadmill running test.

11.3 mmol Dietary Nitrate4.8 mmol Dietary Nitrate8.1 mmol Dietary Nitrate
PlaceboOTHER

Participants received a nitrate-depleted placebo beverage approximately 2.5 hours before the treadmill running test.

Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male adults aged 18 to 40 years.
  • Recreationally trained, performing endurance or combined endurance/resistance exercise at least 3 times per week for the previous 6 months.
  • Maximal oxygen uptake (VO₂max) consistent with recreational training status.
  • Able to perform maximal treadmill running exercise.
  • Willing and able to comply with all study procedures.
  • Provided written informed consent before participation

You may not qualify if:

  • Current smoking or use of nicotine products.
  • History of cardiovascular, pulmonary, metabolic, neurological, or musculoskeletal disorders that could affect exercise performance or participant safety.
  • Current use of medications or dietary supplements known to influence nitric oxide metabolism or exercise performance (e.g., nitrate supplements, phosphodiesterase-5 inhibitors, antibacterial mouthwash).
  • Allergy or intolerance to beetroot or any component of the study supplements.
  • Following a vegetarian or vegan diet, or habitually consuming a high-nitrate diet.
  • Consumption of alcohol, caffeine, or strenuous physical exercise within the period restricted by the study protocol before each experimental visit.
  • Failure to comply with pre-test dietary or behavioral instructions. Participation in another clinical trial within the previous 30 days.
  • Any condition that, in the opinion of the investigators, could interfere with study participation or interpretation of the results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autónoma de Madrid

Madrid, Madrid, 28049, Spain

Location

Related Publications (1)

  • Wylie LJ, Kelly J, Bailey SJ, Blackwell JR, Skiba PF, Winyard PG, Jeukendrup AE, Vanhatalo A, Jones AM. Beetroot juice and exercise: pharmacodynamic and dose-response relationships. J Appl Physiol (1985). 2013 Aug 1;115(3):325-36. doi: 10.1152/japplphysiol.00372.2013. Epub 2013 May 2.

    PMID: 23640589BACKGROUND

Study Officials

  • Helios Pareja Galeano

    Universidad Autonoma de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 30, 2026

Study Start

October 1, 2023

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations