NCT07194720

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2022

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

September 18, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

Cornus mas L.systemic vascular resistanceperipheral chemoreflexendurance trainingnitric oxideendotheliumautonomic nervous systemblood pressure

Outcome Measures

Primary Outcomes (2)

  • Systemic vascular resistance

    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)

    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 Outcomes (2)

  • Peripheral chemoreflex sensitivity

    From the beginning to the end of a supplementation period at 4 weeks.

  • eNOS expression

    From the beginning to the end of a supplementation period at 4 weeks.

Study Arms (2)

Cornus mas lyophilisate

EXPERIMENTAL
Dietary Supplement: Cornus mas lyophilisate

placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Cornus mas lyophilisateDIETARY_SUPPLEMENT

Participants receiving a Cornus mas (Cornelian cherry) lyophilisate for 4 weeks.

Cornus mas lyophilisate
PlaceboDIETARY_SUPPLEMENT

Participants receiving a starch- and sugar-based placebo for 4 weeks.

placebo

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age above 45 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-376, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2025

First Posted

September 26, 2025

Study Start

September 15, 2021

Primary Completion

April 21, 2022

Study Completion

April 21, 2022

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

This is a small trial which includes solely healthy volunteers. Therefore, data will not be shared at this instance.

Locations