Recruiting NCT07090876
Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standardized Grape Seed Extract, Placebo.
- Who it may be relevant to
- Registry conditions: High-normal Blood Pressure. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
Overview
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 supplement 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) - Other Placebo
Placebo
Primary outcome measures
- Treatment-dependent change in SBP [Time frame: 8 weeks]
Secondary outcome measures (10)
- Treatment-dependent change in SBP [Time frame: 4 weeks]
- Treatment-dependent change in DBP [Time frame: 4 weeks]
- Treatment-dependent change in DBP [Time frame: 8 weeks]
- Treatment-dependent change in Augmentation Index [Time frame: 8 weeks]
- Treatment-dependent change in cfPWV [Time frame: 8 weeks]
- Treatment-dependent change in VOI [Time frame: 8 weeks]
- Treatment-dependent change in endothelial reactivity [Time frame: 8 weeks]
- Treatment-dependent change in arterial compliance [Time frame: 8 weeks]
- Treatment-dependent change in the perfusion index [Time frame: 8 weeks]
- Treatment-dependent change in the perceived stress levels [Time frame: 8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Ital — Bologna
Publications
- 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
Identifiers
NCT: NCT07090876 · ZENITH_RCT2025