The Effects of Acute Nitrate and Caffeine Co-ingestion on Discipline-Specific Exercise Performance.
6 августа 2026 г. обновлено: Poznan University of Physical Education
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.
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.
Обзор исследования
Статус
Еще не набирают
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
112
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Natalia Główka, PhD
- Номер телефона: +48691756944
- Электронная почта: glowka@awf.poznan.pl
Места учебы
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Wielkopolska
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Poznan, Wielkopolska, Польша, 61-871
- Poznań University of Physical Education
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Контакт:
- Natalia Główka
- Номер телефона: 691756944
- Электронная почта: glowka@awf.poznan.pl
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Да
Описание
Inclusion Criteria:
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: CAF + BJ (Active Co-ingestion)
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.
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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.
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.
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Активный компаратор: CAF + PLBJ (Caffeine + Placebo BJ)
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.
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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.
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.
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Активный компаратор: PLCAF + BJ (Placebo CAF + Beetroot Juice)
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.
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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.
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).
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Плацебо Компаратор: PLCAF + PLBJ (Double Placebo Control)
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.
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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.
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).
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Exercise Performance Time (minutes and seconds, Cohort A - Hyrox P'F'T)
Временное ограничение: At each experimental visit (Visits T1-T4), with visits conducted at 7-day intervals following the baseline/familiarization visit (T0).
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Total time (in minutes and seconds) required to complete the standardized HYROX Physical Fitness Test (P'F'T) consisting of 6 specific functional exercises.
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At each experimental visit (Visits T1-T4), with visits conducted at 7-day intervals following the baseline/familiarization visit (T0).
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Swimming Performance (minutes and seconds, Cohort B - 8x100m Step-Test)
Временное ограничение: At each experimental visit (Visits T1-T4), with visits conducted at 7-day intervals following the baseline/familiarization visit (T0).
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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.
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At each experimental visit (Visits T1-T4), with visits conducted at 7-day intervals following the baseline/familiarization visit (T0).
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Blood Lactate Kinetics (mmol/L)
Временное ограничение: 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).
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Blood lactate concentration, including peak concentration, accumulation kinetics, and clearance rate, will be assessed from fingertip capillary blood collected before supplementation (baseline), pre-exercise (3 hours after beetroot juice supplementation and 30 minutes after caffeine supplementation), and post-exercise (3 and 7 minutes after exercise) at each experimental visit.
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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).
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Heart Rate (HR, bpm)
Временное ограничение: Continuously monitored during exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Real-time heart rate (beats per minute) will be continuously monitored throughout each exercise test using a telemetry-based heart rate monitoring system.
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Continuously monitored during exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Rating of Perceived Exertion (RPE, points)
Временное ограничение: Immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Subjective rating of perceived exertion will be assessed using the validated Borg Scale (6-20).
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Immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Blood Pressure (mmHg)
Временное ограничение: 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).
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Systolic and diastolic blood pressure will be measured using an automated oscillometric blood pressure monitor.
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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).
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Gastrointestinal Tolerance Profile (mVAS, points)
Временное ограничение: Measured 30 minutes after supplementation and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Gastrointestinal symptoms will be assessed using the modified Visual Analog Scale (mVAS; 0-10, where 0 = no symptoms and 10 = extremely severe symptoms).
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Measured 30 minutes after supplementation and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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White blood cells count and differential (count/L)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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White blood cells count and differential (%)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Hematological indices (red blood cells, RBC) (count/L)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Hematological indices (hemoglobin concentration, HGB) (mmol/L)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Hematological indices (hematocrit, HCT) (L/L)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Hematological indices (mean corpuscular volume, MCV; mean platelet volume, MPV) (fL)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Hematological indices (mean corpuscular hemoglobin mass, MCH) (fmol)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Hematological indices (mean corpuscular hemoglobin concentration, MCHC) (mmol/L)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Hematological indices (platelet count, PLT) (count/L)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Hematological indices (platelet hematocrit, PCT) (cL/L)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Hematological indices (platelet distribution width, PDW; platelet large cell ratio, PLCR; red blood cells distribution width - coefficient of variation, RDW-C) (%)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Hematological indices (red blood cells distribution width - standard deviation, RDW-S) (fL)
Временное ограничение: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Assessment of the hematological parameter will be performed from fingertip capillary blood collected before supplementation (baseline) and 3 minutes after exercise at each experimental visit.
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Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Nutritional status indices (concentration of urea) (mmol/L)
Временное ограничение: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Urea concentration will be assessed from fingertip capillary blood collected before supplementation (baseline).
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Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Creatinine Concentration (μmol/L)
Временное ограничение: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Creatinine concentration will be assessed from fingertip capillary blood collected before supplementation (baseline).
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Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Muscle Damage Markers (ALT, AST, CK, LDH) (U/L)
Временное ограничение: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Activities of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase (CK), and lactate dehydrogenase (LDH) will be assessed from fingertip capillary blood collected before supplementation (baseline).
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Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Body composition (fat-free mass, fat mass) (kg)
Временное ограничение: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Body composition will be assessed before supplementation (baseline) using bioelectrical impedance analysis.
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Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Body composition (fat-free mass, fat mass) (%)
Временное ограничение: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Body composition will be assessed before supplementation (baseline) using bioelectrical impedance analysis.
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Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Body composition (total body water) (L)
Временное ограничение: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Body composition will be assessed before supplementation (baseline) using bioelectrical impedance analysis.
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Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Body composition (total body water) (%)
Временное ограничение: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Body composition will be assessed before supplementation (baseline) using bioelectrical impedance analysis.
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Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Iron Status (Iron, Ferritin, UIBC, TIBC) (μg/dL)
Временное ограничение: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Serum iron concentration, ferritin concentration, unsaturated iron-binding capacity (UIBC), and total iron-binding capacity (TIBC) will be assessed from fingertip capillary blood collected before supplementation (baseline).
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Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Iron Status (Transferrin Concentration) (g/L)
Временное ограничение: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Serum transferrin concentration will be assessed from fingertip capillary blood collected before supplementation (baseline).
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Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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Sleep Quality (Visual Analog Scale, VAS; points)
Временное ограничение: Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Subjective sleep quality will be assessed using a Visual Analog Scale (VAS).
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Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Mood (Brunel Mood Scale, BRUMS; points)
Временное ограничение: Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Mood state will be assessed using the Brunel Mood Scale (BRUMS).
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Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Competitive State Anxiety (Revised Competitive State Anxiety Inventory-2, CSAI-2R; points)
Временное ограничение: Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Competitive state anxiety will be assessed using the Revised Competitive State Anxiety Inventory-2 (CSAI-2R).
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Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Felt Arousal (Felt Arousal Scale, FAS; points)
Временное ограничение: Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Perceived arousal will be assessed using the Felt Arousal Scale (FAS).
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Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Feeling Scale (FS; points)
Временное ограничение: Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Affective valence will be assessed using the Feeling Scale (FS).
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Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Natalia Główka, PhD, Poznan University of Physical Education, Department of Sports Dietetics
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 октября 2026 г.
Первичное завершение (Оцененный)
30 июня 2029 г.
Завершение исследования (Оцененный)
30 июня 2029 г.
Даты регистрации исследования
Первый отправленный
17 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
31 июля 2026 г.
Первый опубликованный (Действительный)
5 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
7 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
6 августа 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ZDS2026_NG_001
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
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.
Сроки обмена IPD
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.
Критерии совместного доступа к IPD
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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .