Hemodynamic Effects of a Standardized Grape Seed Extract Supplementation: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Treatment-dependent change in SBP
研究概览
简要总结
The purpose of this study is to evaluate whether a standardized grape seed extract, compared to placebo, can significantly influence systolic blood pressure (SBP) in individuals with high-normal blood pressure (BP) who are adhering to a low-sodium Mediterranean diet. Additionally, the effects of the grape seed extract on diastolic blood pressure (DBP), other hemodynamic parameters, and the Perceived Stress Score will be assessed.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥18 and ≤70 years;
- •Subjects with high-normal blood pressure levels, defined as SBP 130-139 mmHg and/or DBP 85-89 mmHg (according to ESH criteria);
- •Subjects with an estimated 10-year CVD risk <10% (as per the SCORE risk prediction algorithm of the European Society of Cardiology);
- •Subjects capable of communicating, making themselves understood, and complying with the study requirements;
- •Subjects who agree to participate in the study and have dated and signed the informed consent form.
排除标准
- •Treatment with direct vasodilator drugs or supplements known to affect blood pressure levels;
- •Chronic pharmacological treatments for any clinical condition not stabilized for at least 3 months;
- •Known thyroid, renal, or hepatic dysfunction (including transaminase levels ≥3 times the upper limit of normal [ULN]);
- •Current or past history of alcohol abuse;
- •Pregnancy or breastfeeding;
- •Known intolerance or hypersensitivity to the active ingredients of the investigational dietary supplement;
- •History or clinical evidence of any significant concomitant disease that could compromise subject safety or the ability to complete the study.
研究组 & 干预措施
Dietary supplement
The subjects will be instructed to take 1 tablet of either the dietary supplement or placebo twice a day, during the main meals (breakfast and lunch time), for 8 weeks
干预措施: Standardized Grape Seed Extract (Dietary Supplement)
Placebo
The subjects will be instructed to take 1 tablet of either the dietary supplement or placebo twice a day, during the main meals (breakfast and lunch time), for 8 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Treatment-dependent change in SBP
时间窗: 8 weeks
The primary objective is to assess and compare the effect on SBP after 8 weeks of treatment with either a standardized grape seed extract or placebo, both administered alongside a low-sodium Mediterranean diet (SOC)
次要结局
- Treatment-dependent change in DBP(4 weeks)
- Treatment-dependent change in SBP(4 weeks)
- Treatment-dependent change in DBP(8 weeks)
- Treatment-dependent change in Augmentation Index(8 weeks)
- Treatment-dependent change in cfPWV(8 weeks)
- Treatment-dependent change in VOI(8 weeks)
- Treatment-dependent change in endothelial reactivity(8 weeks)
- Treatment-dependent change in arterial compliance(8 weeks)
- Treatment-dependent change in the perfusion index(8 weeks)
- Treatment-dependent change in the perceived stress levels(8 weeks)