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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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)
Placebo
AOU Policlinico S.Orsola-Malpighi
Bologna, Italy
Treatment-dependent change in SBP
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)
Time frame: 8 weeks
Treatment-dependent change in SBP
To evaluate the effect of the standardized grape seed extract on changes in SBP compared to baseline and placebo after 4 weeks of treatment
Time frame: 4 weeks
Treatment-dependent change in DBP
To evaluate the effect of the standardized grape seed extract on changes in DBP compared to baseline and placebo after 4 weeks of treatment
Time frame: 4 weeks
Treatment-dependent change in DBP
To evaluate the effect of the standardized grape seed extract on changes in DBP compared to baseline and placebo after 8 weeks of treatment
Time frame: 8 weeks
Treatment-dependent change in Augmentation Index
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
Time frame: 8 weeks
Treatment-dependent change in cfPWV
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
Time frame: 8 weeks
Treatment-dependent change in VOI
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
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Time frame: 8 weeks
Treatment-dependent change in endothelial reactivity
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.
Time frame: 8 weeks
Treatment-dependent change in arterial compliance
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.
Time frame: 8 weeks
Treatment-dependent change in the perfusion index
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
Time frame: 8 weeks
Treatment-dependent change in the perceived stress levels
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.
Time frame: 8 weeks