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Cardiovascular PhysiologyNCT07885098

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

A study testing Standardized Tart Cherry and Aronia Extract in people with Cardiovascular Physiology, run by Wroclaw Medical University at 1 site in Poland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 75 years, men onlyHealthy volunteers can take part
Conditions the study is for
Cardiovascular Physiology
What is being tested?
Standardized Tart Cherry and Aronia Extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 sitePoland
Study dates
10 Oct 2026to 30 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Cardiovascular disease
  • Diabetes mellitus
  • Liver or gastrointestinal disease
  • Cancer
  • Inflammatory disease
  • Chronic use of anti-inflammatory medications
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bartłomiej Paleczny, PhD, DSc contact

(+48) 71 784 14 37

bartlomiej.paleczny@umw.edu.pl

Wojciech Łopusiewicz, MSc contact

(+48) 71 784 14 28

wojciech.lopusiewicz@umw.edu.pl

Poland1 site
  • Department of Physiology and Pathophysiology, Wroclaw Medical University

    Wroclaw, 50368

    Bartłomiej Paleczny, PhD, DSc, (+48) 71 784 14 37, bartlomiej.paleczny@umw.edu.pl

Other trials in Poland

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Standardized Tart Cherry and Aronia Extract, Placebo
Keywords
Polyphenols, Anthocyanins, Tart Cherry, Aronia, Endurance Exercise, Flow-Mediated Dilation, Hypoxic Ventilatory Response, Peripheral Chemoreflex, Cardiopulmonary Exercise Testing, Transient Hypoxia Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardized Tart Cherry and Aronia ExtractDietary supplement

    Also called CHG SPORT, CherryGO

    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.

  • PlaceboDietary supplement

    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.

Study groups in NCT07885098
Study groupRoleWhat they receive
CHG SPORT Then PlaceboExperimentalParticipants will receive CHG SPORT for four weeks, followed by a four-week washout period and then placebo for four weeks.
Receives: Dietary Supplement: Standardized Tart Cherry and Aronia Extract; Dietary Supplement: Placebo
Placebo Then CHG SPORTExperimentalParticipants will receive placebo for four weeks, followed by a four-week washout period and then CHG SPORT for four weeks.
Receives: Dietary Supplement: Standardized Tart Cherry and Aronia Extract; Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in total peripheral resistance at rest

    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.

    Measured: Baseline and Day 28 of each intervention period

  2. Change in brachial artery flow-mediated dilation

    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.

    Measured: Baseline and Day 28 of each intervention period

Secondary outcomes (1)
  1. Change in total peripheral resistance response to transient hypoxia

    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.

    Measured: Baseline and Day 28 of each intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2026
  2. Study start10 Oct 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Participants will be randomized to one of two intervention sequences. Sequence 1 will receive CHG SPORT for four weeks, followed by a four-week washout period and then placebo for four weeks. Sequence 2 will receive placebo for four weeks, followed by a four-week washout period and then CHG SPORT for four weeks.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07885098
Sponsor's protocol ID
CHGSPORT-UMW-2026
Other IDs
KB 159/2026
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31264084
  • 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.

    PubMed 22520621
  • 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.

    PubMed 21411615
  • 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.

    PubMed 18258621
  • 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.

    PubMed 21068346
  • 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.

    PubMed 23743811
  • 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.

    PubMed 24742818
  • 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.

    PubMed 25811286
  • 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.

    PubMed 30617467
  • 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.

    PubMed 17320090

Questions about this trial

What is this clinical trial studying?

A study testing Standardized Tart Cherry and Aronia Extract in people with Cardiovascular Physiology, run by Wroclaw Medical University at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bartłomiej Paleczny, PhD, DSc ((+48) 71 784 14 37, bartlomiej.paleczny@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in total peripheral resistance at rest (time frame: Baseline and Day 28 of each intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07885098, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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