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- Essai clinique NCT07885098
Effects of Tart Cherry and Aronia Extract Supplementation on Selected Physiological Parameters in Endurance-Trained Men
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Bartłomiej Paleczny, PhD, DSc
- Numéro de téléphone: (+48) 71 784 14 37
- E-mail: bartlomiej.paleczny@umw.edu.pl
Sauvegarde des contacts de l'étude
- Nom: Wojciech Łopusiewicz, MSc
- Numéro de téléphone: (+48) 71 784 14 28
- E-mail: wojciech.lopusiewicz@umw.edu.pl
Lieux d'étude
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Wroclaw, Pologne, 50368
- Recrutement
- Department of Physiology and Pathophysiology, Wroclaw Medical University
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Contact:
- Bartłomiej Paleczny, PhD, DSc
- Numéro de téléphone: (+48) 71 784 14 37
- E-mail: bartlomiej.paleczny@umw.edu.pl
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
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. |
|
Expérimental: 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.
Autres noms:
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in total peripheral resistance at rest
Délai: 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
|
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Change in brachial artery flow-mediated dilation
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in total peripheral resistance response to transient hypoxia
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in hypoxic ventilatory response
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
|
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Change in skin advanced glycation end-products
Délai: Baseline and Day 28 of each intervention period
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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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Bartłomiej Paleczny, PhD, DSc, Wroclaw Medical University, Department of Physiology and Pathophysiology
- Chercheur principal: Beata Ponikowska, Professor, Wroclaw Medical University, Department of Physiology and Pathophysiology
Publications et liens utiles
Publications générales
- Erlund I, Koli R, Alfthan G, Marniemi J, Puukka P, Mustonen P, Mattila P, Jula A. Favorable effects of berry consumption on platelet function, blood pressure, and HDL cholesterol. Am J Clin Nutr. 2008 Feb;87(2):323-31. doi: 10.1093/ajcn/87.2.323.
- Akbari M, Tamtaji OR, Lankarani KB, Tabrizi R, Dadgostar E, Kolahdooz F, Jamilian M, Mirzaei H, Asemi Z. The Effects of Resveratrol Supplementation on Endothelial Function and Blood Pressures Among Patients with Metabolic Syndrome and Related Disorders: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. High Blood Press Cardiovasc Prev. 2019 Aug;26(4):305-319. doi: 10.1007/s40292-019-00324-6. Epub 2019 Jul 1.
- Tome-Carneiro J, Gonzalvez M, Larrosa M, Yanez-Gascon MJ, Garcia-Almagro FJ, Ruiz-Ros JA, Garcia-Conesa MT, Tomas-Barberan FA, Espin JC. One-year consumption of a grape nutraceutical containing resveratrol improves the inflammatory and fibrinolytic status of patients in primary prevention of cardiovascular disease. Am J Cardiol. 2012 Aug 1;110(3):356-63. doi: 10.1016/j.amjcard.2012.03.030. Epub 2012 Apr 19.
- Dohadwala MM, Holbrook M, Hamburg NM, Shenouda SM, Chung WB, Titas M, Kluge MA, Wang N, Palmisano J, Milbury PE, Blumberg JB, Vita JA. Effects of cranberry juice consumption on vascular function in patients with coronary artery disease. Am J Clin Nutr. 2011 May;93(5):934-40. doi: 10.3945/ajcn.110.004242. Epub 2011 Mar 16.
- Morand C, Dubray C, Milenkovic D, Lioger D, Martin JF, Scalbert A, Mazur A. Hesperidin contributes to the vascular protective effects of orange juice: a randomized crossover study in healthy volunteers. Am J Clin Nutr. 2011 Jan;93(1):73-80. doi: 10.3945/ajcn.110.004945. Epub 2010 Nov 10.
- Wong RH, Berry NM, Coates AM, Buckley JD, Bryan J, Kunz I, Howe PR. Chronic resveratrol consumption improves brachial flow-mediated dilatation in healthy obese adults. J Hypertens. 2013 Sep;31(9):1819-27. doi: 10.1097/HJH.0b013e328362b9d6.
- Khan F, Ray S, Craigie AM, Kennedy G, Hill A, Barton KL, Broughton J, Belch JJ. Lowering of oxidative stress improves endothelial function in healthy subjects with habitually low intake of fruit and vegetables: a randomized controlled trial of antioxidant- and polyphenol-rich blackcurrant juice. Free Radic Biol Med. 2014 Jul;72:232-7. doi: 10.1016/j.freeradbiomed.2014.04.006. Epub 2014 Apr 15.
- Willems ME, Myers SD, Gault ML, Cook MD. Beneficial Physiological Effects With Blackcurrant Intake in Endurance Athletes. Int J Sport Nutr Exerc Metab. 2015 Aug;25(4):367-74. doi: 10.1123/ijsnem.2014-0233. Epub 2015 Mar 26.
- Morgan PT, Barton MJ, Bowtell JL. Montmorency cherry supplementation improves 15-km cycling time-trial performance. Eur J Appl Physiol. 2019 Mar;119(3):675-684. doi: 10.1007/s00421-018-04058-6. Epub 2019 Jan 8.
- Naruszewicz M, Laniewska I, Millo B, Dluzniewski M. Combination therapy of statin with flavonoids rich extract from chokeberry fruits enhanced reduction in cardiovascular risk markers in patients after myocardial infraction (MI). Atherosclerosis. 2007 Oct;194(2):e179-84. doi: 10.1016/j.atherosclerosis.2006.12.032. Epub 2007 Feb 21.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CHGSPORT-UMW-2026
- KB 159/2026 (Autre identifiant: The Bioethics Committee at Wroclaw Medical University)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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