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Effects of Tart Cherry and Aronia Extract Supplementation on Selected Physiological Parameters in Endurance-Trained Men

9 novembre 2026 aggiornato da: Wroclaw Medical University

Effects of Oral Supplementation With a Double-Standardized Extract of Tart Cherry (Prunus Cerasus (Vistula)) and Aronia Berry (Aronia Melanocarpa (Michaux)) on Selected Physiological Parameters in Healthy Endurance-Trained Men

This study will evaluate the effects of four weeks of oral supplementation with a double-standardized tart cherry (Prunus cerasus) and aronia (Aronia melanocarpa) extract on cardiovascular regulation and exercise performance in healthy endurance-trained men aged 40 to 75 years. In a randomized crossover design, 25 participants will receive CHG SPORT and placebo for four weeks each, separated by a four-week washout period. Assessments will include resting cardiovascular and respiratory measurements, cardiovascular and ventilatory responses to transient hypoxia, flow-mediated dilation, skin advanced glycation end products, cardiopulmonary exercise testing, 24-hour ambulatory blood pressure, and blood biomarkers. The study will determine whether CHG SPORT supplementation produces changes in selected cardiovascular and exercise-performance measures compared with placebo.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study is a randomized, placebo-controlled, crossover dietary intervention designed to evaluate the effects of four weeks of supplementation with CHG SPORT, a double-standardized extract of tart cherry (Prunus cerasus, Vistula) and aronia berry (Aronia melanocarpa, Michaux), on cardiopulmonary regulation, vascular function, and exercise performance in healthy endurance-trained men aged 40-75 years.

A total of 25 participants will be enrolled. Participants will be randomized to one of two intervention sequences. In one sequence, participants will receive CHG SPORT for four weeks, followed by a four-week washout period and then placebo for four weeks. In the alternative sequence, placebo will be administered first, followed by the washout period and subsequent CHG SPORT supplementation. The placebo consists of maltodextrin-containing capsules. Physiological assessments will be performed immediately before and at the end of each four-week intervention period, allowing within-participant comparison of responses to CHG SPORT and placebo.

At each assessment, resting cardiovascular and respiratory function will first be evaluated during a 15-20-minute recording in the supine position. Electrocardiography, arterial oxygen saturation, continuous non-invasive arterial blood pressure, inspiratory airflow, and end-tidal carbon dioxide will be recorded simultaneously. Derived variables will include heart rate, systolic, diastolic and mean arterial pressure, stroke volume, cardiac output, total peripheral resistance, tidal volume, respiratory rate, and minute ventilation. The resting recordings will also be used to assess cardiac autonomic regulation using heart rate variability analysis.

Peripheral chemoreflex function will be assessed using the transient hypoxia method. The test will be performed immediately after the resting recording using the same respiratory and cardiovascular monitoring system. While breathing through a face mask connected to a switching respiratory circuit, participants will be exposed to a series of brief periods of pure nitrogen inhalation lasting approximately 5-40 seconds. Individual nitrogen exposures will be separated by at least three minutes of room-air breathing to allow physiological variables to return toward baseline. Each test will include approximately 4-10 hypoxic stimuli of different intensity, producing a range of transient reductions in arterial oxygen saturation. The resulting ventilatory response, including changes in minute ventilation, and cardiovascular responses, including changes in heart rate and arterial blood pressure, will be quantified in relation to the magnitude of oxygen desaturation. This approach will be used to characterize peripheral chemoreflex sensitivity.

Endothelial function will subsequently be evaluated using brachial artery flow-mediated dilation (FMD). After 10-15 minutes of supine rest, the brachial artery will be visualized using high-resolution ultrasound with a linear transducer. The artery will be imaged approximately 3-10 cm above the antecubital fossa and baseline vessel diameter will be determined at end diastole. A pneumatic cuff will then be inflated to suprasystolic pressure, typically 200-250 mmHg, for five minutes. Following rapid cuff deflation, the artery will be continuously imaged for approximately 2-3 minutes during reactive hyperemia. FMD will be calculated as the percentage increase in maximal brachial artery diameter relative to baseline diameter and will be used as a functional measure of endothelium-dependent vasodilation.

Cardiorespiratory exercise capacity will be assessed using a symptom-limited cardiopulmonary exercise test (CPET) performed on a cycle ergometer with continuous analysis of oxygen and carbon dioxide in expired air. Following a one-minute warm-up at 0 W, workload will increase continuously using an individualized ramp protocol of approximately 15-30 W/min while participants maintain a cadence of approximately 60 revolutions per minute. The ramp rate will be selected according to the participant's expected exercise capacity. Variables assessed during CPET will include peak oxygen uptake (VO2), carbon dioxide output, minute ventilation, respiratory rate, heart rate, maximal workload, exercise duration, and aerobic and anaerobic thresholds. Capillary blood lactate will be measured immediately before and immediately after CPET to characterize the metabolic response to exercise.

Additional cardiovascular assessment will include 24-hour ambulatory blood pressure monitoring performed under usual daily living conditions. Tissue accumulation of advanced glycation end-products will also be assessed non-invasively by measurement of skin autofluorescence at the forearm.

Venous blood samples will be obtained immediately before and immediately after each CPET and again approximately 24 hours after exercise. The analyses include selected parameters of metabolic, inflammatory, endothelial, and oxidative-stress profile, including gene-expression markers.

The crossover design allows each participant to serve as his own control. The study will therefore compare changes occurring during four weeks of CHG SPORT supplementation with changes occurring during the corresponding placebo period. The overall objective is to determine whether supplementation with the tart cherry and aronia extract modifies cardiovascular and autonomic regulation, peripheral chemoreflex responsiveness, endothelial function, ambulatory blood pressure, exercise capacity, and selected biochemical responses in healthy endurance-trained men.

Tipo di studio

Interventistico

Iscrizione (Stimato)

25

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Wroclaw, Polonia, 50368
        • Reclutamento
        • Department of Physiology and Pathophysiology, Wroclaw Medical University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • Male sex
  • Age 40 to 75 years
  • Active participation in endurance sports, including running, cycling, or other - endurance disciplines, with at least two training sessions per week

Exclusion Criteria:

  • Cardiovascular disease
  • Diabetes mellitus
  • Liver or gastrointestinal disease
  • Cancer
  • Inflammatory disease
  • Chronic use of anti-inflammatory medications
  • Alcohol or drug abuse
  • Current tobacco smoking
  • Autoimmune disease
  • Acute infection within two months before planned study participation
  • Use of dietary supplements containing high amounts of polyphenols within two months before planned study participation
  • Lack of written informed consent

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: CHG SPORT Then Placebo

Participants will receive CHG SPORT for four weeks, followed by a four-week washout period and then placebo for four weeks.

Oral capsules containing 400 mg per capsule of a double-standardized extract of Prunus cerasus (Vistula) and Aronia melanocarpa (Michaux). The Prunus cerasus extract is standardized to a minimum of 15% polyphenols and 3% anthocyanins (DER 40:1), and the Aronia melanocarpa extract is standardized to a minimum of 50% polyphenols and 25% anthocyanins (DER 70:1). The intervention will be administered for four weeks during the active supplementation period.

Altri nomi:
  • CHG SPORT
  • CherryGO

Maltodextrin-based placebo capsules visually matched to CHG SPORT capsules and supplied in identical containers. The placebo will be administered according to the same dosing schedule and for the same four-week duration as the active intervention.

Sperimentale: Placebo Then CHG SPORT

Participants will receive placebo for four weeks, followed by a four-week washout period and then CHG SPORT for four weeks.

Oral capsules containing 400 mg per capsule of a double-standardized extract of Prunus cerasus (Vistula) and Aronia melanocarpa (Michaux). The Prunus cerasus extract is standardized to a minimum of 15% polyphenols and 3% anthocyanins (DER 40:1), and the Aronia melanocarpa extract is standardized to a minimum of 50% polyphenols and 25% anthocyanins (DER 70:1). The intervention will be administered for four weeks during the active supplementation period.

Altri nomi:
  • CHG SPORT
  • CherryGO

Maltodextrin-based placebo capsules visually matched to CHG SPORT capsules and supplied in identical containers. The placebo will be administered according to the same dosing schedule and for the same four-week duration as the active intervention.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in total peripheral resistance at rest
Lasso di tempo: Baseline and Day 28 of each intervention period

Change in resting total peripheral resistance (TPR) from baseline to the end of each 4-week intervention period. TPR will be derived from continuous non-invasive arterial blood pressure recordings obtained during the resting supine recording. Lower values after intervention indicate a reduction in resting TPR.

Baseline and Day 28 of each intervention period
Change in brachial artery flow-mediated dilation
Lasso di tempo: Baseline and Day 28 of each intervention period

Change in brachial artery flow-mediated dilation (FMD), expressed as the percentage increase in maximal brachial artery diameter during reactive hyperemia relative to baseline diameter, from baseline to the end of each 4-week intervention period.

Baseline and Day 28 of each intervention period

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in total peripheral resistance response to transient hypoxia
Lasso di tempo: Baseline and Day 28 of each intervention period

Total peripheral resistance (TPR) response to hypoxia will be quantified as the absolute value of the slope of the regression line relating TPR to arterial oxygen saturation (SpO2) during the transient hypoxia test. For each nitrogen-breathing episode, one pre-hypoxic and one post-hypoxic point will be included. The pre-hypoxic point will represent mean SpO2 and mean TPR during the 40-second period preceding nitrogen administration. The post-hypoxic point will represent the SpO2 nadir and the corresponding minimum TPR value within a window extending from 10 seconds before to 30 seconds after the SpO2 nadir. The regression will be fitted using all pre- and post-hypoxic points obtained during the test. The slope will be expressed as an absolute value; therefore, a higher value indicates a greater reduction in TPR in response to a given decrease in SpO2 and thus a stronger vascular response to hypoxia.

Baseline and Day 28 of each intervention period

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in hypoxic ventilatory response
Lasso di tempo: Baseline and Day 28 of each intervention period

Hypoxic ventilatory response (HVR) will be quantified as the absolute value of the slope of the regression line relating inspiratory minute ventilation (VI) to arterial oxygen saturation (SpO2) during the transient hypoxia test. For each nitrogen-breathing episode, the pre-hypoxic point will represent mean SpO2 and mean VI during the 40-second period preceding nitrogen administration. The post-hypoxic point will represent the SpO2 nadir and the mean of the three highest VI values within a window extending from 10 seconds before to 30 seconds after the SpO2 nadir. The regression will be fitted using all pre- and post-hypoxic points obtained during the test. The slope will be expressed as an absolute value, with higher values indicating greater peripheral chemosensitivity.

Baseline and Day 28 of each intervention period
Change in peak oxygen uptake (VO2peak)
Lasso di tempo: Baseline and Day 28 of each intervention period

Change in peak oxygen uptake (VO2peak) from baseline to the end of each 4-week intervention period. VO2max will be determined during symptom-limited cardiopulmonary exercise testing performed on a cycle ergometer using an individualized ramp protocol with continuous analysis of respiratory gases.

Baseline and Day 28 of each intervention period
Change in the standard deviation of normal-to-normal RR intervals (SDNN)
Lasso di tempo: Baseline and Day 28 of each intervention period

Change in the standard deviation of normal-to-normal RR intervals (SDNN) from baseline to the end of each 4-week intervention period. SDNN will be derived from resting electrocardiographic recordings as a time-domain measure of heart rate variability.

Baseline and Day 28 of each intervention period
Change in plasma asymmetric dimethylarginine concentration
Lasso di tempo: Baseline and Day 28 of each intervention period

Change in plasma asymmetric dimethylarginine (ADMA) concentration from baseline to the end of each 4-week intervention period. ADMA is assessed as a circulating marker related to nitric oxide bioavailability and endothelial function.

Baseline and Day 28 of each intervention period
Change in Interleukin-6
Lasso di tempo: Baseline and Day 28 of each intervention period

Change in plasma interleukin-6 (IL-6) concentration from baseline to the end of each 4-week intervention period.

Baseline and Day 28 of each intervention period
Change in skin advanced glycation end-products
Lasso di tempo: Baseline and Day 28 of each intervention period

Change in skin advanced glycation end-products (AGEs) from baseline to the end of each 4-week intervention period. Tissue accumulation of AGEs will be assessed non-invasively by measurement of skin autofluorescence at the forearm.

Baseline and Day 28 of each intervention period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Investigatori

  • Investigatore principale: Bartłomiej Paleczny, PhD, DSc, Wroclaw Medical University, Department of Physiology and Pathophysiology
  • Investigatore principale: Beata Ponikowska, Professor, Wroclaw Medical University, Department of Physiology and Pathophysiology

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 novembre 2026

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

30 agosto 2027

Date di iscrizione allo studio

Primo inviato

13 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 ottobre 2026

Primo Inserito (Effettivo)

21 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • CHGSPORT-UMW-2026
  • KB 159/2026 (Altro identificatore: The Bioethics Committee at Wroclaw Medical University)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .