The Effects of Acute Nitrate and Caffeine Co-ingestion on Discipline-Specific Exercise Performance.
6. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
112
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Natalia Główka, PhD
- Telefonní číslo: +48691756944
- E-mail: glowka@awf.poznan.pl
Studijní místa
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Wielkopolska
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Poznan, Wielkopolska, Polsko, 61-871
- Poznań University of Physical Education
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Kontakt:
- Natalia Główka
- Telefonní číslo: 691756944
- E-mail: glowka@awf.poznan.pl
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: 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.
|
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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Aktivní komparátor: 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.
|
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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Komparátor placeba: 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.
|
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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Exercise Performance Time (minutes and seconds, Cohort A - Hyrox P'F'T)
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Blood Lactate Kinetics (mmol/L)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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 (%)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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) (%)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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) (%)
Časové okno: 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)
Časové okno: 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) (%)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
|
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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Natalia Główka, PhD, Poznan University of Physical Education, Department of Sports Dietetics
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. října 2026
Primární dokončení (Odhadovaný)
30. června 2029
Dokončení studie (Odhadovaný)
30. června 2029
Termíny zápisu do studia
První předloženo
17. července 2026
První předloženo, které splnilo kritéria kontroly kvality
31. července 2026
První zveřejněno (Aktuální)
5. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
7. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
6. srpna 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ZDS2026_NG_001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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.
Časový rámec sdílení 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.
Kritéria přístupu pro sdílení 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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .