Overview
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®.
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.
Eligibility
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.
