Clinical trial NCT06982365: Study to Investigate the Potential Health Benefits of Grapes Seeds Extract Supplementation in the Management of Elevated Blood Pressure or Stage 1 Hypertension
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elevated Blood Pressure
Hypertension
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Systolic and Diastolic Blood Pressure
timeFrame: Baseline (Week 0) and Week 8.
Secondary outcomes:
measure: Change in Mood (Positive and Negative Affect Schedule - PANAS Total Score)
timeFrame: Baseline and Week 8.
measure: Change in Emotional Well-being (Warwick-Edinburgh Mental Well-being Scale - WEMWBS Total Score)
timeFrame: Baseline and Week 8.
measure: Change in Perceived Stress (Perceived Stress Questionnaire - PSQ-20 Total Score)
timeFrame: Baseline and Week 8.
measure: Change in Lipid Profile
timeFrame: Baseline and Week 8.
measure: Change in Systemic Inflammation (hs-CRP Levels)
timeFrame: Baseline and Week 8.
measure: Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Enovita®)
timeFrame: Baseline to Week 8.
Other outcomes:
Locations:
city: Jāmshoro
country: Pakistan
facility: Liaquat University of Medical & Health Sciences (LUMHS)
state: Sindh
Study officials:
References:
citation: 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.
citation: 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.