Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation

NCT07090876 | Recruiting

• 1 other identifier: ZENITH_RCT2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

High-normal blood pressure; Grape seed extract; Dietary supplementation; Dietary supplement; Randomized clinical study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Treatment-dependent change in SBP

  4 weeks

• Treatment-dependent change in DBP

  4 weeks

• Treatment-dependent change in DBP

  8 weeks

• Treatment-dependent change in Augmentation Index

  8 weeks

• Treatment-dependent change in cfPWV

  8 weeks

Study Arms (2)

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

Dietary Supplement: Standardized Grape Seed Extract

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

Other: Placebo

Interventions

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)

Dietary supplement

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indena S.p.A: lead

Study Sites (1)

Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy

Bologna, Bo, 40100, Italy

RECRUITING

Related Publications (3)

• 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 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.

  PMID: 39458455 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.

  PMID: 24171039 BACKGROUND

Central Study Contacts

Giovanna Petrangolini, BD

CONTACT

+39 02 57496493; giovanna.petrangolini@indena.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 29, 2025
• Study Start: April 10, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)