Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation
Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
Indena S.p.A
60 participants
Apr 10, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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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Interventions
Grape seed dry extract standardized to provide: ≥95.0% of proanthocyanidins by spectrophotometry, ≥5.0% ≤15.0% of catechin and epicatechin by High-Performance Liquid Chromatography (HPLC)
Placebo
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07090876