High-normal Blood Pressure
Conditions
Keywords
High-normal blood pressure, Grape seed extract, Dietary supplementation, Dietary supplement, Randomized clinical study
Brief 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.
Interventions
DIETARY_SUPPLEMENTStandardized 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)
OTHERPlacebo
Placebo
Sponsors
Indena S.p.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-dependent change in SBP | 4 weeks | To evaluate the effect of the standardized grape seed extract on changes in SBP compared to baseline and placebo after 4 weeks of treatment |
| Treatment-dependent change in DBP | 4 weeks | To evaluate the effect of the standardized grape seed extract on changes in DBP compared to baseline and placebo after 4 weeks of treatment |
| Treatment-dependent change in Augmentation Index | 8 weeks | To evaluate the effect of the standardized grape seed extract on changes in augmentation index compared to baseline and placebo after 8 weeks of treatment |
| Treatment-dependent change in cfPWV | 8 weeks | To evaluate the effect of the standardized grape seed extract on changes in the carotid-femoral pulse wave velocity (cfPWV) compared to baseline and placebo after 8 weeks of treatment |
| Treatment-dependent change in VOI | 8 weeks | To evaluate the effect of the standardized grape seed extract on changes in the vascular overload index (VOI) compared to baseline and placebo after 8 weeks of treatment |
| Treatment-dependent change in endothelial reactivity | 8 weeks | Change in endothelial reactivity from baseline after 8 weeks of treatment with standardized grape seed extract, compared to placebo, as assessed using the Endocheck® module integrated into the Vicorder® system. This method evaluates endothelium-dependent vasodilation through digital pulse volume (PV) analysis in response to reactive hyperemia. The outcome is expressed as the percent change (%) in pulse volume from baseline to peak post-occlusion values, serving as a validated surrogate marker of endothelial function. |
| Treatment-dependent change in arterial compliance | 8 weeks | Change from baseline in arterial compliance, evaluated as the ratio between stroke volume (SV) and pulse pressure (PP) (SV/PP ratio), following 8 weeks of treatment with standardized grape seed extract compared to placebo. |
| Treatment-dependent change in the perfusion index | 8 weeks | To evaluate the effect of the standardized grape seed extract on changes in perfusion index compared to baseline and placebo after 8 weeks of treatment |
| Treatment-dependent change in the perceived stress levels | 8 weeks | Change from baseline in perceived stress levels after 8 weeks of treatment with standardized grape seed extract compared to placebo, measured using the Perceived Stress Scale (PSS) developed by Cohen and Williamson (1988). The PSS is a validated 10-item self-report questionnaire that assesses the degree to which situations in one's life are appraised as stressful over the past month. The questions concern the participant's feelings and thoughts during the last month. For each item, the participant indicates how often they felt or thought a certain way by circling the frequency. Scores range from 0 to 40, with higher scores indicating higher perceived stress levels. The outcome is expressed as the change in total PSS score from baseline. |
Countries
Italy
Contacts
CONTACTGiovanna Petrangolini, BD
Outcome results
None listed