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

NCT ID: NCT06982365

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-11-27

Brief Summary

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®.

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

Study Design

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

Study Groups

Enovita® Group (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.

Group Type: EXPERIMENTAL

Enovita® (Grape Seed Extract)

Intervention Type: 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 Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type: OTHER

Participants in this group will receive a matching placebo capsule identical in appearance to the Enovita® capsule, taken orally, twice daily for 8 weeks.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Other Intervention Names

Matching Placebo Capsule

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Amjad Khan

Professor of Clinical Biochemistry and Experimental medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Liaquat University of Medical & Health Sciences (LUMHS)

Jāmshoro, Sindh, Pakistan

Countries

Pakistan

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)

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

LUMHS/REC/-734/12.05.2025

Identifier Type: -

Identifier Source: org_study_id