Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation (ZENITH)

Indena

Status: Not yet enrolling

Conditions: High-normal Blood Pressure

Treatments: Other: Placebo; Dietary Supplement: Standardized Grape Seed Extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT07090876

ZENITH_RCT2025

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Dietary supplement

Active Comparator group

Description:

The subjects will be instructed to take 1 tablet of either the dietary supplement or placebo twice a day, during the main meals (breakfast and lunch time), for 8 weeks

Treatment:

Dietary Supplement: Standardized Grape Seed Extract

Placebo

Placebo Comparator group

Description:

The subjects will be instructed to take 1 tablet of either the dietary supplement or placebo twice a day, during the main meals (breakfast and lunch time), for 8 weeks

Treatment:

Other: Placebo