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New treatment option for High-normal Blood Pressure
Official title Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation
ClinicalTrials.gov ID: NCT07090876
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Male or female people aged ≥18 and ≤70 years;
- people with high-normal blood pressure levels, defined as SBP 130-139 mmHg and/or DBP 85-89 mmHg (according to ESH criteria);
- people with an estimated 10-year CVD risk \<10% (as per the SCORE risk prediction algorithm of the European Society of Cardiology);
- people capable of communicating, making themselves understood, and complying with the study requirements;
- people who agree to participate in the study and have dated and signed the informed consent form.
You likely can't join 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;
See the full eligibility criteria
- Male or female people aged ≥18 and ≤70 years;
- people with high-normal blood pressure levels, defined as SBP 130-139 mmHg and/or DBP 85-89 mmHg (according to ESH criteria);
- people with an estimated 10-year CVD risk \<10% (as per the SCORE risk prediction algorithm of the European Society of Cardiology);
- people capable of communicating, making themselves understood, and complying with the study requirements;
- people who agree to participate in the study and have dated and signed the informed consent form.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Bo, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Bo, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.