Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation

NCT ID: NCT07090876

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-01-30

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.

Conditions

High-normal Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dietary supplement

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

Group Type: ACTIVE_COMPARATOR

Standardized Grape Seed Extract

Intervention Type: 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)

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indena S.p.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AOU Policlinico S.Orsola-Malpighi

Bologna, , Italy

Countries

Italy

Central Contacts

Giovanna Petrangolini, BD

Role: CONTACT

giovanna.petrangolini@indena.com

+39 02 57496493

Facility Contacts

Arrigo Francesco Giuseppe Cicero, MD, PhD

Role: primary

arrigo.cicero@unibo.it

References

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.

Reference Type: BACKGROUND

PMID: 33671310 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39458455 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24171039 (View on PubMed)

Other Identifiers

ZENITH_RCT2025

Identifier Type: -

Identifier Source: org_study_id