High-normal Blood PressureZENITHNCT07090876
Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation
A study testing Standardized Grape Seed Extract in people with High-normal Blood Pressure, run by Indena S.p.A at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- High-normal Blood Pressure
- What is being tested?
- Standardized Grape Seed Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy
Bologna, Bo, 40100
Arrigo Francesco Giuseppe Cicero, MD, PhD, +39 051 2142224, arrigo.cicero@unibo.it
About this study
Official title: Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
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
- Being tested
- Standardized Grape Seed Extract, Placebo
- Keywords
- High-normal blood pressure, Grape seed extract, Dietary supplementation, Dietary supplement, Randomized clinical study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Grape Seed ExtractDietary 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)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks
Secondary outcomes (10)
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
Measured: 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 4 weeks of treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start10 Apr 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for High-normal Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indena S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090876
- Sponsor's protocol ID
- ZENITH_RCT2025
- Acronym
- ZENITH
- Status last verified
- Apr 2026
- First submitted
- 17 Jul 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33671310Hasbal-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.
PubMed 39458455Belcaro 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.
PubMed 24171039
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
- ClinicalTrials.gov ID
- NCT07090876
- Acronym / sponsor ID
- ZENITH / ZENITH_RCT2025
- Conditions
- High-normal Blood Pressure
- Keywords
- High-normal blood pressure, Grape seed extract, Dietary supplementation, Dietary supplement, Randomized clinical study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Indena S.p.AIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Active comparator | Dietary Supplement: Standardized Grape Seed ExtractThe 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 | Other: PlaceboThe 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Grape Seed ExtractGrape 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 | Dietary supplement |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Treatment-dependent change in SBP
Time frame: 8 weeks
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)
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 33671310Schon 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.
- Background: PubMed 39458455Hasbal-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.
- Background: PubMed 24171039Belcaro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Grape Seed Extract in people with High-normal Blood Pressure, run by Indena S.p.A at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanna Petrangolini, BD (+39 02 57496493, giovanna.petrangolini@indena.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-dependent change in SBP (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07090876, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.