Grape seed extract for lowering high-normal blood pressure

Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial

This will test whether a standardized grape seed extract can lower systolic blood pressure in adults with high-normal blood pressure who follow a low-sodium Mediterranean diet.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Indena S.p.A (industry)
• Locations: 1 site (Bologna, Bo)
• Trial ID: NCT07090876 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–70 with systolic BP 130–139 mmHg and/or diastolic BP 85–89 mmHg, a 10-year CVD risk <10%, able to follow a low-sodium Mediterranean diet and attend study visits are ideal candidates.

Not a fit: People taking blood-pressure–affecting drugs or supplements, with unstable chronic conditions, significant liver or kidney disease, pregnant or breastfeeding, or with higher cardiovascular risk are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If effective, the supplement could offer a non-pharmacological option to modestly lower systolic blood pressure and potentially reduce long-term cardiovascular risk in people with high-normal blood pressure.

How similar studies have performed: Small randomized trials and meta-analyses report modest blood-pressure reductions with grape seed extract, but findings are mixed and larger rigorous trials are limited.

Eligibility criteria

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 this trial is running

Bologna, Bo

• Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy — Bologna, Bo, Italy (RECRUITING)

Study contacts

• Study coordinator: Giovanna Petrangolini, BD

Conditions: High-normal Blood Pressure, High-normal blood pressure, Grape seed extract, Dietary supplementation, Dietary supplement, Randomized clinical study