- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07194720
- Original Trial
Effects of the Cornelian Cherry Supplementation on the Selected Physiological Parameters in Marathon Runners
Effects of the Cornelian Cherry (Cornus Mas L.) Lyophilisate Supplementation on the Selected Physiological Parameters in Amateur Long-Distance Runners
Growing body of evidence indicates favorable effects of Cornus mas (Cornelian cherry) supplements on cardiometabolic risk, including the improvement of HDL and glycemic indices, in line with vascular benefits. Experimental data feature bioactives from Cornelian cherry as potential modulators of vascular function and blood pressure, plausibly via endothelial nitric oxide-related pathways, with possible downstream effects on autonomic reflex control; nevertheless, such links in humans remain poorly explored to date, especially in terms of endurance training and hypoxia tolerance.
In this cross-over, placebo-controlled study, a group of healthy amateur long-distance runners underwent two stages of a four-week dietary intervention (separated by four weeks of washout period), receiving Cornelian cherry lyophilisate or placebo. Each supplementation stage was accompanied by the comprehensive evaluation of the cardio-respiratory parameters and endothelial function.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Poland, 50-376
- Wroclaw Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age above 45 years
Exclusion Criteria:
- chronic disease of the nervous, cardiovascular or respiratory system
- disease of the digestive system, including history of the intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance and other malabsorption disorders
- blood pressure-lowering treatment within the past year
- tobacco smoking within the past year
- antibiotic/probiotic treatment and laxative/prokinetic usage in three months preceding the anticipated enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
|
Participants receiving a starch- and sugar-based placebo for 4 weeks.
|
|
Experimental: Cornus mas lyophilisate
|
Participants receiving a Cornus mas (Cornelian cherry) lyophilisate for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systemic vascular resistance
Time Frame: From the beginning to the end of a supplementation period at 4 weeks.
|
Resting systemic vascular resistance, evaluated non-invasively with a finger cuff-based device.
|
From the beginning to the end of a supplementation period at 4 weeks.
|
|
Office blood pressure values (mean, systolic, diastolic)
Time Frame: From the beginning to the end of a supplementation period at 4 weeks.
|
Resting arterial blood pressure values (mean, systolic, diastolic), measured continuously with a non-invasive, finger cuff-based device.
|
From the beginning to the end of a supplementation period at 4 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peripheral chemoreflex sensitivity
Time Frame: From the beginning to the end of a supplementation period at 4 weeks.
|
Peripheral chemoreflex sensitivity, measured with the transient hypoxia test.
|
From the beginning to the end of a supplementation period at 4 weeks.
|
|
eNOS expression
Time Frame: From the beginning to the end of a supplementation period at 4 weeks.
|
Endothelial nitric oxide synthase expression, evaluated in the peripheral blood samples.
|
From the beginning to the end of a supplementation period at 4 weeks.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DEREN.23.25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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