Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation
Recruiting now · Not applicable · Has a placebo group
Conditions studied: High-normal Blood Pressure
In brief
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.
Key facts
- Study ID
- NCT07090876
- Run by
- Indena S.p.A
- People needed
- 60
- Starts
- 2026-04-10
- Expected to finish
- 2027-01-30
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy — Bologna, Bo, Italy (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.