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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplement | Active Comparator | 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 |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Grape Seed Extract | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Treatment-dependent change in DBP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanna Petrangolini, BD | Contact | +39 02 57496493 | giovanna.petrangolini@indena.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy | Recruiting | Bologna | Bo | 40100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33671310 | Background | Schon C, Allegrini P, Engelhart-Jentzsch K, Riva A, Petrangolini G. Grape Seed Extract Positively Modulates Blood Pressure and Perceived Stress: A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Volunteers. Nutrients. 2021 Feb 17;13(2):654. doi: 10.3390/nu13020654. | |
| 39458455 | Background | Hasbal-Celikok G, Kara M, Sanchez M, Owsianik C, Gomez-Serranillos P, Yilmaz-Ozden T, Oztas E, Zengin OS, Ozhan G, Arda N, Tunc M, Sahin S, Shafiq A, Kanwal A, Ujjan HI, Rabbani F, Petrangolini G, Khan A. In Vitro Mechanistic Studies of a Standardized Sustainable Grape Seed Extract for Potential Application as a Mood-Modulating and Cognition-Enhancing Supplement. Nutrients. 2024 Oct 12;16(20):3459. doi: 10.3390/nu16203459. |
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| Placebo | Other | Placebo |
|
To evaluate the effect of the standardized grape seed extract on changes in DBP compared to baseline and placebo after 4 weeks of treatment
| 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 | 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 | 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 | 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 | 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. | 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. | 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 | 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. | 8 weeks |
| 24171039 | Background | Belcaro G, Ledda A, Hu S, Cesarone MR, Feragalli B, Dugall M. Grape seed procyanidins in pre- and mild hypertension: a registry study. Evid Based Complement Alternat Med. 2013;2013:313142. doi: 10.1155/2013/313142. Epub 2013 Sep 19. |