NCT06982365

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
OTHER	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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-11-07
• Completion: 2025-11-27
• First posted: 2025-05-21
• Last updated: 2025-12-05

Locations

1 site across 1 country: Pakistan