Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation

Официальное название

Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial

Обзор

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.

Вмешательства

• Пищевая добавка Standardized 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)
• Другое Placebo
  Placebo

Первичные конечные точки

• Treatment-dependent change in SBP [Срок оценки: 8 weeks]

Вторичные конечные точки (10)

• Treatment-dependent change in SBP [Срок оценки: 4 weeks]
• Treatment-dependent change in DBP [Срок оценки: 4 weeks]
• Treatment-dependent change in DBP [Срок оценки: 8 weeks]
• Treatment-dependent change in Augmentation Index [Срок оценки: 8 weeks]
• Treatment-dependent change in cfPWV [Срок оценки: 8 weeks]
• Treatment-dependent change in VOI [Срок оценки: 8 weeks]
• Treatment-dependent change in endothelial reactivity [Срок оценки: 8 weeks]
• Treatment-dependent change in arterial compliance [Срок оценки: 8 weeks]
• Treatment-dependent change in the perfusion index [Срок оценки: 8 weeks]
• Treatment-dependent change in the perceived stress levels [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Ital — Bologna

Публикации

• 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. PMID 33671310
• 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 PMID 39458455
• 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. PMID 24171039

Идентификаторы

NCT: NCT07090876 · ZENITH_RCT2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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