Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation (NCT07090876) | Clinical Trial Compass
RecruitingNot Applicable
Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation
Italy60 participantsStarted 2026-04-10
Plain-language summary
The purpose of this study is to evaluate whether a standardized grape seed extract, compared to placebo, can significantly influence systolic blood pressure (SBP) in individuals with high-normal blood pressure (BP) who are adhering to a low-sodium Mediterranean diet. Additionally, the effects of the grape seed extract on diastolic blood pressure (DBP), other hemodynamic parameters, and the Perceived Stress Score will be assessed.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Male or female subjects aged ≥18 and ≤70 years;
* Subjects with high-normal blood pressure levels, defined as SBP 130-139 mmHg and/or DBP 85-89 mmHg (according to ESH criteria);
* Subjects with an estimated 10-year CVD risk \<10% (as per the SCORE risk prediction algorithm of the European Society of Cardiology);
* Subjects capable of communicating, making themselves understood, and complying with the study requirements;
* Subjects who agree to participate in the study and have dated and signed the informed consent form.
Exclusion Criteria:
* Treatment with direct vasodilator drugs or supplements known to affect blood pressure levels;
* Chronic pharmacological treatments for any clinical condition not stabilized for at least 3 months;
* Known thyroid, renal, or hepatic dysfunction (including transaminase levels ≥3 times the upper limit of normal \[ULN\]);
* Current or past history of alcohol abuse;
* Pregnancy or breastfeeding;
* Known intolerance or hypersensitivity to the active ingredients of the investigational dietary supplement;
* History or clinical evidence of any significant concomitant disease that could compromise subject safety or the ability to complete the study.