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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Systolic and Diastolic Blood Pressure
研究概览
简要总结
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®.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both participants and study personnel (care providers, investigators, and outcome assessors) will be blinded to group allocation. The Enovita® and placebo capsules will be identical in appearance, packaging, and labeling to ensure blinding.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Enovita® (Grape Seed Extract) (Dietary Supplement)
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.
干预措施: Placebo Capsule (Other)
结局指标
主要结局
Change in Systolic and Diastolic Blood Pressure
时间窗: 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.
次要结局
- Change in Systemic Inflammation (hs-CRP Levels)(Baseline and Week 8.)
- Change in Mood (Positive and Negative Affect Schedule - PANAS Total Score)(Baseline and Week 8.)
- Change in Perceived Stress (Perceived Stress Questionnaire - PSQ-30 Total Score)(Baseline and Week 8.)
- Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Enovita®)(Baseline to Week 8.)
- Change in Mood (Positive and Negative Affect Schedule - PANAS Total Score)(Baseline and Week 8.)
- Change in Perceived Stress (Perceived Stress Questionnaire - PSQ-30 Total Score)(Baseline and Week 8.)
- Change in Lipid Profile(Baseline and Week 8.)
- Change in Systemic Inflammation (hs-CRP Levels)(Baseline and Week 8.)
- Incidence and Severity of Treatment-Emergent Adverse Events (Safety and Tolerability of Enovita®)(Baseline to Week 8.)
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental medicine
Liaquat University of Medical & Health Sciences