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

6 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

112

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Wielkopolska
      • Poznan, Wielkopolska, Polen, 61-871
        • Poznań University of Physical Education
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
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.
Actieve vergelijker: 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.
Actieve vergelijker: 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).
Placebo-vergelijker: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Exercise Performance Time (minutes and seconds, Cohort A - Hyrox P'F'T)
Tijdsspanne: At each experimental visit (Visits T1-T4), with visits conducted at 7-day intervals following the baseline/familiarization visit (T0).
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)
Tijdsspanne: At each experimental visit (Visits T1-T4), with visits conducted at 7-day intervals following the baseline/familiarization visit (T0).
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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood Lactate Kinetics (mmol/L)
Tijdsspanne: 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).
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.
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)
Tijdsspanne: Continuously monitored during exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Real-time heart rate (beats per minute) will be continuously monitored throughout each exercise test using a telemetry-based heart rate monitoring system.
Continuously monitored during exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Rating of Perceived Exertion (RPE, points)
Tijdsspanne: Immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Subjective rating of perceived exertion will be assessed using the validated Borg Scale (6-20).
Immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Blood Pressure (mmHg)
Tijdsspanne: 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).
Systolic and diastolic blood pressure will be measured using an automated oscillometric blood pressure monitor.
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)
Tijdsspanne: Measured 30 minutes after supplementation and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Gastrointestinal symptoms will be assessed using the modified Visual Analog Scale (mVAS; 0-10, where 0 = no symptoms and 10 = extremely severe symptoms).
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)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
White blood cells count and differential (%)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
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)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
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)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Hematological indices (hematocrit, HCT) (L/L)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
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)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
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)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Hematological indices (mean corpuscular hemoglobin concentration, MCHC) (mmol/L)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Hematological indices (platelet count, PLT) (count/L)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Hematological indices (platelet hematocrit, PCT) (cL/L)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Hematological indices (platelet distribution width, PDW; platelet large cell ratio, PLCR; red blood cells distribution width - coefficient of variation, RDW-C) (%)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Hematological indices (red blood cells distribution width - standard deviation, RDW-S) (fL)
Tijdsspanne: Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
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.
Before supplementation (baseline) and 3 minutes after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Nutritional status indices (concentration of urea) (mmol/L)
Tijdsspanne: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Urea concentration will be assessed from fingertip capillary blood collected before supplementation (baseline).
Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Creatinine Concentration (μmol/L)
Tijdsspanne: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Creatinine concentration will be assessed from fingertip capillary blood collected before supplementation (baseline).
Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Muscle Damage Markers (ALT, AST, CK, LDH) (U/L)
Tijdsspanne: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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).
Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Body composition (fat-free mass, fat mass) (kg)
Tijdsspanne: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Body composition will be assessed before supplementation (baseline) using bioelectrical impedance analysis.
Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Body composition (fat-free mass, fat mass) (%)
Tijdsspanne: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Body composition will be assessed before supplementation (baseline) using bioelectrical impedance analysis.
Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Body composition (total body water) (L)
Tijdsspanne: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Body composition will be assessed before supplementation (baseline) using bioelectrical impedance analysis.
Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Body composition (total body water) (%)
Tijdsspanne: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Body composition will be assessed before supplementation (baseline) using bioelectrical impedance analysis.
Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Iron Status (Iron, Ferritin, UIBC, TIBC) (μg/dL)
Tijdsspanne: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
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).
Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Iron Status (Transferrin Concentration) (g/L)
Tijdsspanne: Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Serum transferrin concentration will be assessed from fingertip capillary blood collected before supplementation (baseline).
Before supplementation (baseline) at each experimental visit (Visits T1-T4; 7-day intervals).
Sleep Quality (Visual Analog Scale, VAS; points)
Tijdsspanne: Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Subjective sleep quality will be assessed using a Visual Analog Scale (VAS).
Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Mood (Brunel Mood Scale, BRUMS; points)
Tijdsspanne: Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Mood state will be assessed using the Brunel Mood Scale (BRUMS).
Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Competitive State Anxiety (Revised Competitive State Anxiety Inventory-2, CSAI-2R; points)
Tijdsspanne: 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).
Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Felt Arousal (Felt Arousal Scale, FAS; points)
Tijdsspanne: Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Perceived arousal will be assessed using the Felt Arousal Scale (FAS).
Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Feeling Scale (FS; points)
Tijdsspanne: Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).
Affective valence will be assessed using the Feeling Scale (FS).
Before supplementation (baseline), pre-exercise, and immediately after exercise at each experimental visit (Visits T1-T4; 7-day intervals).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Natalia Główka, PhD, Poznan University of Physical Education, Department of Sports Dietetics

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

30 juni 2029

Studie voltooiing (Geschat)

30 juni 2029

Studieregistratiedata

Eerst ingediend

17 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

31 juli 2026

Eerst geplaatst (Werkelijk)

5 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

6 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren