NCT07748416

Brief Summary

The purpose of this study is to investigate the acute, separate, and combined ergogenic effects of dietary nitrate (beetroot juice, BJ) and caffeine (CAF) supplementation on discipline-specific athletic performance. The project employs a double-blind, randomized, placebo-controlled, four-arm crossover design. It evaluates two highly distinct, heterogeneous populations of athletes: (A) adult high-intensity functional training (HIFT/CrossFit/Hyrox) competitors performing the standardized Hyrox Physical Fitness Test (P'F'T), and (B) elite junior competitive swimmers (National Team members) performing a progressive 8 × 100 m swimming test. The study will assess physical performance, lactate kinetics, subjective exertion, biochemical indices, psychological metrics, and gastrointestinal tolerance.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 17, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

August 7, 2026

Status Verified

July 1, 2026

Enrollment Period

2.7 years

First QC Date

July 17, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

CaffeineSports nutritionSwimmingHigh-Intensity Functional TrainingNitric oxide

Outcome Measures

Primary Outcomes (2)

  • Exercise Performance Time (minutes and seconds, Cohort A - Hyrox P'F'T)

    Total time (in minutes and seconds) required to complete the standardized HYROX Physical Fitness Test (P'F'T) consisting of 6 specific functional exercises.

    At each experimental visit (Visits T1-T4), with visits conducted at 7-day intervals following the baseline/familiarization visit (T0).

  • Swimming Performance (minutes and seconds, Cohort B - 8x100m Step-Test)

    Swimming performance will be assessed using the completion time (seconds and milliseconds) for each 100-m repetition of the standardized 8 × 100-m step test, including the maximal-effort repetition performed during the fifth stage.

    At each experimental visit (Visits T1-T4), with visits conducted at 7-day intervals following the baseline/familiarization visit (T0).

Secondary Outcomes (31)

  • Blood Lactate Kinetics (mmol/L)

    Before supplementation (baseline), pre-exercise (3 hours after beetroot juice supplementation and 30 minutes after caffeine supplementation), and 3 and 7 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).

  • Heart Rate (HR, bpm)

    Continuously monitored during exercise at each experimental visit (Visits T1-T4; 7-day intervals).

  • Rating of Perceived Exertion (RPE, points)

    Immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).

  • Blood Pressure (mmHg)

    Measured 2.5 hours after beetroot juice supplementation and 30 minutes after caffeine supplementation (pre-exercise) at each experimental visit (Visits T1-T4; 7-day intervals).

  • Gastrointestinal Tolerance Profile (mVAS, points)

    Measured 30 minutes after supplementation and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).

  • +26 more secondary outcomes

Study Arms (4)

CAF + BJ (Active Co-ingestion)

EXPERIMENTAL

Participants ingest a concentrated beetroot juice shot (\~6.4 mmol / 400 mg nitrates) 3 hours before exercise, and a capsule of caffeine (Cohort A: 6 mg/kg body mass; Cohort B: 3 mg/kg body mass) 60 minutes before exercise.

Dietary Supplement: CaffeineDietary Supplement: Dietary Nitrate (Beetroot Juice)

CAF + PLBJ (Caffeine + Placebo BJ)

ACTIVE COMPARATOR

Participants ingest a nitrate-depleted beetroot juice shot (\~0.04 mmol nitrates) 3 hours before exercise, and a capsule of caffeine (Cohort A: 6 mg/kg body mass; Cohort B: 3 mg/kg body mass) 60 minutes before exercise.

Dietary Supplement: CaffeineDietary Supplement: Placebo (Nitrate-Depleted Beetroot Juice)

PLCAF + BJ (Placebo CAF + Beetroot Juice)

ACTIVE COMPARATOR

Participants ingest a concentrated beetroot juice shot (\~6.4 mmol / 400 mg nitrates) 3 hours before exercise, and a placebo capsule (maltodextrin) 60 minutes before exercise.

Dietary Supplement: Dietary Nitrate (Beetroot Juice)Dietary Supplement: Placebo (Maltodextrin Capsule)

PLCAF + PLBJ (Double Placebo Control)

PLACEBO COMPARATOR

Participants ingest a nitrate-depleted beetroot juice shot (\~0.04 mmol nitrates) 3 hours before exercise, and a placebo capsule (maltodextrin) 60 minutes before exercise.

Dietary Supplement: Placebo (Maltodextrin Capsule)Dietary Supplement: Placebo (Nitrate-Depleted Beetroot Juice)

Interventions

CaffeineDIETARY_SUPPLEMENT

Anhydrous caffeine administered orally in a hard gelatine capsule. To address the unique physiological profiles of the two cohorts, a highly specific, differentiated dosing protocol is implemented: Cohort A (adult functional fitness athletes) will receive a high-performance dose of 6 mg/kg body mass, while Cohort B (elite junior swimmers) will receive a safe, youth-adapted dose of 3 mg/kg body mass. In all experimental trials, the capsule is ingested exactly 60 minutes prior to the onset of the discipline-specific exercise test to match peak plasma caffeine concentration.

CAF + BJ (Active Co-ingestion)CAF + PLBJ (Caffeine + Placebo BJ)

Concentrated beetroot juice (BJ) administered as a single, acute organic shot of 70 mL (Beet It Sport, James White Drinks Ltd., Ipswich, UK). Each active shot contains approximately 400 mg (equivalent to \~6.4 mmol) of inorganic nitrate. In contrast to chronic loading designs, this study evaluates purely acute effects; the shot is ingested exactly 3 hours (180 minutes) prior to the physical performance test to align with peak systemic concentration of plasma nitrite.

CAF + BJ (Active Co-ingestion)PLCAF + BJ (Placebo CAF + Beetroot Juice)

Placebo capsule containing inert maltodextrin powder. The capsule is identical in size, shape, weight, color (opaque), and texture to the active caffeine capsule to ensure robust blinding. It is administered at the exact same time point (60 minutes pre-exercise) according to the identical body-mass-adjusted dosing scheme (simulating either 3 mg/kg or 6 mg/kg).

PLCAF + BJ (Placebo CAF + Beetroot Juice)PLCAF + PLBJ (Double Placebo Control)

Nitrate-depleted beetroot juice (Beet It, James White Drinks Ltd., Ipswich, UK) administered as a 70 mL shot. This placebo is identical in taste, smell, appearance, packaging, and viscosity to the active concentrated shot, but has been selectively filtered to contain negligible nitrate levels (\<0.4 mmol / \~25 mg of nitrates). It is ingested exactly 3 hours prior to the exercise test.

CAF + PLBJ (Caffeine + Placebo BJ)PLCAF + PLBJ (Double Placebo Control)

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A) Cohort A (HIFT / CrossFit / Hyrox):
  • Aged 18-45 years.
  • Minimum of 2 years of systematic HIFT/CrossFit/Hyrox training experience.
  • Performing \>4 training sessions per week.
  • Ability to perform the HYROX Physical Fitness Test (P'F'T) and has participated in at least one official HYROX event.
  • Possession of a valid medical certificate proving eligibility for competitive sports.
  • B) Cohort B (Competitive Junior Swimmers):
  • Aged 16-19 years.
  • Active member of the Polish Junior National Swimming Team.
  • Minimum of 5 years of competitive swimming experience.
  • Current training volume of at least 8-10 pool training sessions per week.
  • Written informed consent obtained from both the participant and their legal guardian (for minors under 18).
  • C)Common Criteria for Both Cohorts:
  • No history of cardiovascular, respiratory, metabolic, or musculoskeletal disease contradicting high-intensity exercise or stimulant intake.
  • No known food allergies or adverse reactions to beetroot products or caffeine.
  • +4 more criteria

You may not qualify if:

  • Occurrence of acute musculoskeletal injury or trauma during the study period.
  • Any medical or health contraindications (including severe menstrual disorders, planned pregnancy, or breastfeeding).
  • Failure or refusal to strictly adhere to the dietary, supplementation, and exercise testing protocols.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Physical Education

Poznan, Wielkopolska, 61-871, Poland

Location

MeSH Terms

Interventions

Caffeinemaltodextrin

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Natalia Główka, PhD

    Poznan University of Physical Education, Department of Sports Dietetics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Główka, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This study employs a double-blind, randomized, placebo-controlled, four-arm, crossover design to evaluate the acute, separate, and combined effects of caffeine (CAF) and dietary nitrate (beetroot juice, BJ) on athletic performance. Following a baseline familiarization session (T0), participants will complete four main experimental testing visits (T1-T4). Every participant will undergo all four interventional conditions in a randomized, counterbalanced sequence. A minimum 7-day (168-hour) washout period will separate each testing session to ensure complete physical recovery, muscle regeneration, and complete elimination of the active substances from the systemic circulation. The four interventional combinations administered across the testing visits are: Active BJ + Active CAF (CAF+BJ); Active CAF + BJ (CAF+PLBJ); Active BJ + Placebo CAF (PLCAF+BJ); Placebo BJ + Placebo CAF (PLCAF+PLBJ).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2026

First Posted

August 5, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

August 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

The study protocol will be published as an open-access article. Upon completion of the study, de-identified individual participant data (IPD) and relevant analytic code will be deposited in an open-access repository such as Zenodo or OSF, following the FAIR principles.

Shared Documents
STUDY PROTOCOL
Time Frame
The study protocol will be available upon its publication. The IPD and analytic code will be available starting from the date of the primary study results publication and will remain accessible for at least 5 years.
Access Criteria
The study protocol will be published as an open-access article. Upon completion of the study, de-identified individual participant data (IPD) and relevant analytic code will be deposited in an open-access repository such as Zenodo or OSF, in accordance with FAIR principles.

Locations