Elevated Blood PressureNCT06982365

Study to Investigate the Potential Health Benefits of Grapes Seeds Extract Supplementation in the Management of Elevated Blood Pressure or Stage 1 Hypertension

A study testing Enovita® (Grape Seed Extract) in people with Elevated Blood Pressure and Hypertension, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Elevated Blood Pressure, Hypertension
What is being tested?: Enovita® (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: 80 participants
Where: 1 sitePakistan
Study dates: 1 Aug 2025to 27 Nov 2025
Phase: Interventional
Are there results?: None posted in the registry

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 30 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults aged 30 to 65 years.
Diagnosed with Elevated Blood Pressure (systolic 120-129 mmHg and diastolic <80 mmHg) or Stage 1 Hypertension (systolic 130-139 mmHg or diastolic 80-89 mmHg), according to American Heart Association guidelines.
No use of antihypertensive medication in the past 3 months.
Willing to comply with study procedures and follow-up visits.
Able to provide written informed consent.

Who cannot join

Stage 2 Hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) at screening.
Chronic kidney disease (eGFR < 60 mL/min/1.73 m²).
Diabetes mellitus (HbA1c ≥ 6.5%).
History of cardiovascular events (myocardial infarction, stroke) in the past 6 months.
Known allergy to grape products.
Current use of polyphenol supplements or similar herbal products.
Pregnancy or breastfeeding.
Participation in another clinical trial within the last 30 days.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Liaquat University of Medical & Health Sciences (LUMHS)
Jāmshoro, Sindh, 76090

Other trials in Pakistan

About this study

Official title: Study to Investigate the Potential Health Benefits of Grapes Seeds Extract Supplementation in the Management of Elevated Blood Pressure or Stage 1 Hypertension: A Pragmatic Randomized, Double-blind Placebo Controlled Trial

This study is a pragmatic, randomized, double-blind, placebo-controlled trial aimed at evaluating the potential health benefits of Enovita® (standardized grape seed extract) supplementation in adults with elevated blood pressure or Stage 1 hypertension. The primary objective is to assess the impact of Enovita® on systolic and diastolic blood pressure over 8 weeks. Secondary outcomes include changes in mood, emotional well-being, perceived stress, lipid profile, and systemic inflammation. The study will also monitor the safety and tolerability of Enovita®.

Read the detailed description

Hypertension is a major risk factor for cardiovascular diseases, and its early management is crucial. Grape seed extract is a natural polyphenol-rich supplement that may offer antihypertensive benefits through its antioxidant, anti-inflammatory, and vasodilatory properties. This study aims to investigate the effectiveness of a standardized Grape seeds extract, Enovita® in reducing blood pressure in adults with elevated blood pressure or Stage 1 hypertension.

This is a pragmatic, randomized, double-blind, placebo-controlled trial involving two groups: the Enovita® group receiving 150 mg of Enovita® twice daily and the placebo group receiving matching placebo capsules. The intervention will last for 8 weeks. Participants will be assessed at baseline, 4 weeks, and 8 weeks.

The primary outcome is the change in systolic and diastolic blood pressure from baseline to 8 weeks. Secondary outcomes include changes in mood (PANAS and WEMWBS scores), perceived stress (PSQ-20 score), lipid profile (total cholesterol, LDL, HDL, triglycerides), and systemic inflammation (hs-CRP levels). Safety will be monitored through adverse event reporting and regular health assessments.

This study will provide insights into the potential of Enovita® as a natural intervention for managing mild hypertension and improving emotional well-being.

Conditions: Elevated Blood Pressure, Hypertension
Being tested: Enovita® (Grape Seed Extract), Placebo Capsule
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enovita® (Grape Seed Extract)Dietary supplement
Enovita® is a standardized grape seed extract containing polyphenols, known for their antioxidant and vasodilatory properties. Participants in this group will take 150 mg of Enovita® orally, twice daily (total daily dose: 300 mg) for 8 weeks.
Placebo CapsuleOther
Also called Matching Placebo Capsule
Participants in this group will receive a matching placebo capsule identical in appearance to the Enovita® capsule, taken orally, twice daily for 8 weeks.

Study groups in NCT06982365
Study group	Role	What they receive
Enovita® Group (Grape Seed Extract)	Experimental	Participants in this group will receive Enovita®, a standardized grape seed extract. Each participant will take 150 mg of Enovita® orally, twice daily (total daily dose: 300 mg) for a duration of 8 weeks. Receives: Dietary Supplement: Enovita® (Grape Seed Extract)
Placebo Group	Placebo comparator	Participants in this group will receive a matching placebo capsule, identical in appearance to the Enovita® capsule. Each participant will take one placebo capsule orally, twice daily, for a duration of 8 weeks. Receives: Other: Placebo Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Systolic and Diastolic Blood Pressure
Evaluation of the change in systolic and diastolic blood pressure (measured in mmHg) from baseline (Week 0) to the end of the study (Week 8). Blood pressure will be measured using a validated automatic sphygmomanometer in a seated position, following standardized protocols.
Measured: Baseline (Week 0) and Week 8.

Secondary outcomes (5)

Change in Mood (Positive and Negative Affect Schedule - PANAS Total Score)
Assessment of mood using the Positive and Negative Affect Schedule (PANAS), a self-reported questionnaire measuring both positive and negative emotional states. Each subscale (Positive Affect and Negative Affect) consists of 10 items scored from 1 to 5, resulting in subscale scores ranging from 10 to 50. Higher Positive Affect scores indicate better mood, while higher Negative Affect scores indicate worse mood.
Participants will complete the PANAS at Baseline (Week 0) and Week 8.
Measured: Baseline and Week 8.
Change in Perceived Stress (Perceived Stress Questionnaire - PSQ-30 Total Score)
Measurement of perceived stress using the Perceived Stress Questionnaire (PSQ-30), a standardized 20-item self-reported measure. Each item is rated on a 4-point Likert scale. The PSQ-20 total score is scaled between 0 (lowest stress) and 1 (highest stress). Higher scores reflect greater perceived stress. Participants will complete the questionnaire at Baseline and Week 8.
Measured: Baseline and Week 8.
Change in Lipid Profile
Assessment of lipid profile using fasting blood samples, measuring total cholesterol, LDL, HDL, and triglycerides levels.
Measured: Baseline and Week 8.
Change in Systemic Inflammation (hs-CRP Levels)
Measurement of high-sensitivity C-reactive protein (hs-CRP) levels in fasting blood samples as a marker of systemic inflammation.
Measured: Baseline and Week 8.
Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Enovita®)
Monitoring and recording of treatment-emergent adverse events (TEAEs) throughout the study. This includes the number of participants experiencing one or more TEAEs, the type of event, severity (mild, moderate, severe), and relationship to the investigational product (Enovita®). All events will be collected from Baseline through Week 8.
Measured: Baseline to Week 8.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202527 Nov 2025

First posted21 May 2025
Study start1 Aug 2025
Primary completion7 Nov 2025
Study completion27 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Elevated 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
Model description: A randomized, double-blind, placebo-controlled, parallel-group design. Participants are randomly assigned to one of two groups: Group 1: Enovita® (Grape Seed Extract) 150 mg twice daily. Group 2: Placebo (Matching capsule) twice daily.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06982365
Sponsor's protocol ID: LUMHS/REC/-734/12.05.2025
Status last verified: Nov 2025
First submitted: 12 May 2025
Last updated: 5 Dec 2025
Results posted: No
Data monitoring committee: Yes
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 33671310
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.
PubMed 24171039

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Investigate the Potential Health Benefits of Grapes Seeds Extract Supplementation in the Management of Elevated Blood Pressure or Stage 1 Hypertension: A Pragmatic Randomized, Double-blind Placebo Controlled Trial
ClinicalTrials.gov ID: NCT06982365
Acronym / sponsor ID: LUMHS/REC/-734/12.05.2025
Conditions: Elevated Blood Pressure, Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Liaquat University of Medical & Health SciencesUniversity, hospital or other
Study start: 1 Aug 2025 (actual)
Primary completion: 7 Nov 2025 (actual)
Study completion: 27 Nov 2025 (actual)
First posted: 21 May 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.

Detailed description

This study will provide insights into the potential of Enovita® as a natural intervention for managing mild hypertension and improving emotional well-being.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: A randomized, double-blind, placebo-controlled, parallel-group design. Participants are randomly assigned to one of two groups: Group 1: Enovita® (Grape Seed Extract) 150 mg twice daily. Group 2: Placebo (Matching capsule) twice daily.

Arm	Type	Receives
Enovita® Group (Grape Seed Extract)	Experimental	Dietary Supplement: Enovita® (Grape Seed Extract)Participants in this group will receive Enovita®, a standardized grape seed extract. Each participant will take 150 mg of Enovita® orally, twice daily (total daily dose: 300 mg) for a duration of 8 weeks.
Placebo Group	Placebo comparator	Other: Placebo CapsuleParticipants in this group will receive a matching placebo capsule, identical in appearance to the Enovita® capsule. Each participant will take one placebo capsule orally, twice daily, for a duration of 8 weeks.

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adults aged 30 to 65 years.
Diagnosed with Elevated Blood Pressure (systolic 120-129 mmHg and diastolic <80 mmHg) or Stage 1 Hypertension (systolic 130-139 mmHg or diastolic 80-89 mmHg), according to American Heart Association guidelines.
No use of antihypertensive medication in the past 3 months.
Willing to comply with study procedures and follow-up visits.
Able to provide written informed consent.

Key exclusion criteria (8 listed)

Stage 2 Hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) at screening.
Chronic kidney disease (eGFR < 60 mL/min/1.73 m²).
Diabetes mellitus (HbA1c ≥ 6.5%).
History of cardiovascular events (myocardial infarction, stroke) in the past 6 months.
Known allergy to grape products.

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
Enovita® (Grape Seed Extract)Enovita® is a standardized grape seed extract containing polyphenols, known for their antioxidant and vasodilatory properties. Participants in this group will take 150 mg of Enovita® orally, twice daily (total daily dose: 300 mg) for 8 weeks.	Dietary supplement	Enovita® Group (Grape Seed Extract)
Placebo CapsuleAlso: Matching Placebo CapsuleParticipants in this group will receive a matching placebo capsule identical in appearance to the Enovita® capsule, taken orally, twice daily for 8 weeks.	Other	Placebo Group

Primary outcome

Change in Systolic and Diastolic Blood Pressure
Time frame: Baseline (Week 0) and Week 8.
Evaluation of the change in systolic and diastolic blood pressure (measured in mmHg) from baseline (Week 0) to the end of the study (Week 8). Blood pressure will be measured using a validated automatic sphygmomanometer in a seated position, following standardized protocols.

5 secondary outcomes

Change in Mood (Positive and Negative Affect Schedule - PANAS Total Score)
Time frame: Baseline and Week 8.
Change in Perceived Stress (Perceived Stress Questionnaire - PSQ-30 Total Score)
Time frame: Baseline and Week 8.
Change in Lipid Profile
Time frame: Baseline and Week 8.
Change in Systemic Inflammation (hs-CRP Levels)
Time frame: Baseline and Week 8.
Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Enovita®)
Time frame: Baseline to Week 8.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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 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

Related trials for Elevated Blood Pressure

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enovita® (Grape Seed Extract) in people with Elevated Blood Pressure and Hypertension, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.

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 8 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: finished, as of the sponsor's last update on 5 Dec 2025. 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 Pakistan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic and Diastolic Blood Pressure (time frame: Baseline (Week 0) and Week 8.). 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 NCT06982365, which also lists 2 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 5 Dec 2025.