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Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation

RecruitingNAAges 18 Years - 70 YearsAllIndena S.p.A
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Standardized Grape Seed Extract
  • Placebo
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Where

1 site
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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