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Набор скоро начнётся NCT07748416

The Effects of Acute Nitrate and Caffeine Co-ingestion on Discipline-Specific Exercise Performance.

Без фазы С лечением Athletic Performance Dietary Supplement Iron Status

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Caffeine, Dietary Nitrate (Beetroot Juice), Placebo (Maltodextrin Capsule), Placebo (Nitrate-Depleted Beetroot Juice).
Кому может быть актуально
Состояния в реестре: Athletic Performance, Dietary Supplement, Iron Status. Базовые параметры: 16 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Acute Effects of Dietary Nitrate (Beetroot Juice), Caffeine, and Their Combination on Discipline-Specific Exercise Performance, Lactate Kinetics, and Physiological Responses in Trained Functional Fitness Athletes and Elite Junior Swimmers.

Обзор

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.

Подробное описание

This project addresses a critical gap in sports nutrition literature regarding the potential synergistic, additive, or antagonistic interactions of caffeine (CAF) and dietary nitrate (beetroot juice, BJ) when co-administered. While CAF acts primarily as an adenosine receptor antagonist in the central nervous system to enhance motor unit recruitment and decrease perceived exertion, BJ acts as a physiological precursor to nitric oxide, improving peripheral muscle contractility, mitochondrial efficiency, and muscle perfusion.

To evaluate whether these effects are universal or discipline-specific, the trial employs a two-population cohort design:

* Cohort A (HIFT/Hyrox): Investigates adult functional fitness athletes (aged 18-45) characterized by concurrent strength and endurance adaptations. They will perform the ecological Hyrox P'F'T. * Cohort B (Elite Junior Swimmers): Investigates elite junior national team swimmers (aged 16-19) during their centralized training camp. They will undergo the standardized progressive 8 × 100 m step-test.

Furthermore, this study will analyze whether individual hematological markers (iron status) and biochemical profiles correlate with the magnitude of the ergogenic response to establish prospective predictive biomarkers for customized sports nutrition.

Вмешательства

  • Пищевая добавка Caffeine
    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
  • Пищевая добавка Dietary Nitrate (Beetroot Juice)
    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.
  • Пищевая добавка Placebo (Maltodextrin Capsule)
    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).
  • Пищевая добавка Placebo (Nitrate-Depleted Beetroot Juice)
    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.

Первичные конечные точки

  • Exercise Performance Time (minutes and seconds, Cohort A - Hyrox P'F'T) [Срок оценки: 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) [Срок оценки: At each experimental visit (Visits T1-T4), with visits conducted at 7-day intervals following the baseline/familiarization visit (T0).]
Вторичные конечные точки (12)
  • Blood Lactate Kinetics (mmol/L) [Срок оценки: 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) [Срок оценки: Continuously monitored during exercise at each experimental visit (Visits T1-T4; 7-day intervals).]
  • Rating of Perceived Exertion (RPE, points) [Срок оценки: Immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).]
  • Blood Pressure (mmHg) [Срок оценки: 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) [Срок оценки: Measured 30 minutes after supplementation and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).]
  • White blood cells count and differential (count/L) [Срок оценки: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).]
  • White blood cells count and differential (%) [Срок оценки: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).]
  • Hematological indices (red blood cells, RBC) (count/L) [Срок оценки: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).]
  • Hematological indices (hemoglobin concentration, HGB) (mmol/L) [Срок оценки: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).]
  • Hematological indices (hematocrit, HCT) (L/L) [Срок оценки: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).]
  • Hematological indices (mean corpuscular volume, MCV; mean platelet volume, MPV) (fL) [Срок оценки: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).]
  • Hematological indices (mean corpuscular hemoglobin mass, MCH) (fmol) [Срок оценки: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).]

Критерии участия

Критерии включения

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.
  • No current use of medications that alter nitrate/caffeine metabolism (e.g., proton pump inhibitors, antibiotics, phosphodiesterase inhibitors).
  • History of uneventful habituation to caffeine use during training/competition.
  • Willingness to abstain from dietary supplements, antibacterial mouthwashes, alcohol, and high-nitrate foods for 48 hours prior to each testing session.
  • Good general health and physical well-being.

Exclusion Criteria (Applicable to both cohorts):

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Четверное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Польша · 1 центр
  • Poznan University of Physical Education — Poznan

Идентификаторы

NCT: NCT07748416 · ZDS2026_NG_001

Первоисточники (государственные реестры)

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