Grape seed extract for lowering high-normal blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled study compares a standardized grape seed extract supplement to placebo in adults aged 18–70 with high-normal blood pressure who are following a low-sodium Mediterranean diet. The primary outcome is change in systolic blood pressure, with secondary outcomes including diastolic blood pressure, other hemodynamic parameters, and the Perceived Stress Score. Eligible participants must have a 10-year cardiovascular risk below 10% and no unstable chronic conditions or confounding medications. The trial is sponsored by Indena S.p.A and conducted at the Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
  Bologna, Bo, Italy Recruiting

Study contacts

• Study coordinator: Giovanna Petrangolini, BD
• Email: giovanna.petrangolini@indena.com
• Phone: +39 02 57496493

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.