Ireland
--:--IST
Recruiting Not applicable

Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation

NCT07090876 · tracked via the Priya Life Science Italy tracker
Sponsor
Indena S.p.A
Phase
Not applicable
Started
2026-04-10
Last updated
2026-04-22

Condition(s) studied

High-normal Blood Pressure

Investigational drug(s) / intervention(s)

Standardized Grape Seed ExtractPlacebo

Standardized Grape Seed Extract: 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: Placebo

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Treatment-dependent change in SBP — 8 weeks
    The primary objective is to assess and compare the effect on SBP after 8 weeks of treatment with either a standardized grape seed extract or placebo, both administered alongside a low-sodium Mediterranean diet (SOC)

Trial sites (1)

FacilityCityRegionStatus
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy Bologna Bo Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07090876 on ClinicalTrials.gov ↗ ← All trials in Italy