Actively Recruiting
Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation
Led by Indena S.p.A · Updated on 2026-04-22
60
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 69;18 and 69;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 will not qualify if you...
- 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 69;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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, Bo, Italy, 40100
Actively Recruiting
Research Team
G
Giovanna Petrangolini, BD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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